HOCl Wound Irrigation System, per-patient bag and single-use head (Aquaceso; variant)

If it is false: Neither the referrer nor any party it can bring in holds or can license the Aquaceso hardware. Then there is no existing head, shield and bag to co-pack with an HOCl solution. The kit becomes a new-hardware development programme (design, tooling, verification, its own regulatory route), and the referred premise — adding HOCl to a system already on the market — no longer exists.

Depends on it: Commercial, Legal & IP, Operations & NPI

If it is false: K123072 is not an FRO clearance describing HOCl as a preservative, with cleansing, irrigation and debridement indications for acute and chronic wounds. Then the launch route (device_class row 1) loses its primary predicate and the preservative framing the intended use copies. The solution needs another predicate, or a De Novo.

Depends on it: Regulatory

If it is false: No cleared HOCl solution is supplied in bulk irrigation bags (1-3 L) for irrigation. The bag format then has no precedent, and stability and preservative-effectiveness data for HOCl in a flexible irrigation bag must be generated without a predicate to bridge to.

Depends on it: Regulatory, Technology & R&D

If it is false: Proposed rule 2023-26209 has been finalized. If HOCl sits in the high-AMR-concern tier, liquid wound washes containing it are Class III: the FRO 510(k) launch route closes and a PMA replaces it, and the P0 the original shape calendar and capital do not fit. If HOCl sits in the Class II tier, the route survives but must meet special controls nobody here has read.

Depends on it: Regulatory, Commercial

If it is false: 880.6960 is not Class I and exempt, or does not reach a spray head with a splash shield. The hardware half then has no low-burden route of its own. If FDA reads the kit as two parts, the head and shield need their own clearance, and the neighbouring shape (hardware for third-party HOCl) is no longer the cheap fallback.

Depends on it: Regulatory, Operations & NPI

If it is false: IRRISEPT K080779 was not cleared as a solution-dispensing irrigation system under jet lavage FQH. The alternative reading in device_class row 2 then has no precedent for a non-powered antimicrobial-preserved system in that regulation, and the kit is left with the FRO route alone, fully exposed to A4 Generator's belief.

Depends on it: Regulatory

If it is false: Carter et al. 2023 does not report about 10.5 million Medicare beneficiaries with a wound. The TAM chain then loses its only population figure. The three components (claims 36-38) already carry no number, so TAM has no denominator and stays unscored as a core factor.

Depends on it: Commercial

If it is false: The 2024 network meta-analysis does not rank NaOCl/HOCl highest for healing. The strongest pooled comparative evidence for choosing HOCl over saline or water then disappears, and the reason a buyer would pay for HOCl rather than tap water (Aquaceso's default irrigant) has no comparative evidence under it. The label cannot make this claim either way (claim 10unconfirmed); demand depends on clinicians believing it.

Depends on it: Clinical & Scientific, Commercial

If it is false: The IWII 2022 consensus does not discuss HOCl as a wound-cleansing option. Clinician adoption, and the quality criteria of a Danish tender, then have no consensus-document anchor. A11 "The efficacy of combination of sodium… becomes the only clinical argument, and it is a single meta-analysis with known limits.

Depends on it: Clinical & Scientific, Commercial

If it is false: A live claim in the US 8,871,278 stabilized-hypohalous-acid family, believed held by Urgo, reads on the HOCl solution the kit would use. The solution half then needs a licence from Urgo, or supply from a licensed source, or a formulation design-around. Without one of those, FTO for the solution is blocked, and that is the rubric's automatic kill. This row is what would force the shape toward neighbouring shape (c), co-branding with an incumbent.

Depends on it: Legal & IP, Commercial

If it is false: A live claim in the Schultz / Splash Medical Devices family (US 8,002,757 and continuations) reads on a splash shield mounted on an irrigation fluid source. The head-and-shield hardware then needs a licence or a design-around before US sale, and FTO for the hardware half is blocked until expiry.

Depends on it: Legal & IP, Technology & R&D

If it is false: The HOCl solution or kit is not Class IIb under the MDR. If it is Class III under Rule 14, the EU route needs a notified body plus a medicinal-substance consultation and a heavier clinical evaluation. The referrer's Danish home market then moves from a IIb certification, with precedent (claim 22unconfirmed), to a Class III programme.

Depends on it: Regulatory (EU), Commercial

If it is false: Danish regional and municipal wound-care tenders award on price, not on quality and working environment. In the referrer's home market the kit then competes against sterile NaCl at commodity price, and the premium that the closed-kit shape needs (A8 Assumption, US) has no Danish counterpart either.

Depends on it: Commercial (DK), Market Access

If it is false: 42 CFR 419.2(b)(4) does not package medical and surgical supplies into the hospital outpatient prospective payment. P0 the original shape's buyer in that setting is the facility, paying from a supply budget that the bundled rate funds. That buyer then has no Medicare money behind the purchase. No other Medicare line replaces it, because A6260 is non-covered under Part B (claim 29verified). The hospital outpatient setting in intended_use: keeps its users and loses its payer. Market Access would need a separate-payment route, and P0 the original shape has none.

Depends on it: Market Access, Commercial

If it is false: The SNF Part A per diem does not pay in full for ancillary supplies, or 411.15(p) does not pull an outside supplier's item into the SNF's own payment. During a Part A stay the SNF is then not the economic buyer P0 the original shape sells to. The kit would fall to Part B as A6260, which is non-covered (claim 29verified). The SNF setting in intended_use: then has no payer.

Depends on it: Market Access, Commercial

If it is false: The home health episode payment does not cover medical supplies, or 409.100(a)(2) does not route their payment to the agency. The home health agency is then not the buyer. The kit falls to Part B as A6260 and is non-covered (claim 29verified), so the home health setting in intended_use: has no payer except the patient.

Depends on it: Market Access, Commercial

If it is false: The July 2026 DMEPOS amounts for 500 mL sterile saline (A4217) and an irrigation syringe (A4322) are not as stated. Then the only published price in the file for the cheapest comparator, saline with a syringe, is gone. A8 Assumption's cost-in-use case has no number on its low side. These are Medicare allowed amounts, not facility purchase prices, and neither code is paid separately in the settings of A19 Restates the OPPS part of claim 30 on its…-A21 42 CFR 484.205.

Depends on it: Commercial, Market Access

If it is false: The online list prices for a 34 oz (1 L) Vashe bottle (case of 6 at $849.98) and a 32 oz Puracyn Plus bottle (case of 6 at $440.98) are not as listed. Then A8 Assumption's second comparator, an HOCl bottle, has no observed price at all. The band the kit has to price inside, from saline with a syringe (A22 Price anchor for the saline comparator) up to an HOCl bottle, has no upper edge. This is one retailer's list price on one day, not a contract price, and it does not fill the TAM price leg (claim 37unconfirmed).

Depends on it: Commercial

If it is false: Urgo did not announce a Premier GPO agreement that covers Vashe. Then the file holds no evidence that US facilities buy HOCl wound cleansers through GPO contracting. That is the channel to the supply budgets of A19 Restates the OPPS part of claim 30 on its…-A21 42 CFR 484.205 that P0 the original shape's facility-buyer model assumes. Its federal counterpart is the Vashe FSS contract (claim 104verified). Neither discloses a price.

Depends on it: Commercial, Market Access

If it is false: The CMS 2024 national service counts for 97597, 11042, 11043 and 11045 are not as stated. Then the TAM loses its only verified volume figure. The volume component (claim 36unconfirmed) asserts no number, and A9 TAM denominator is a count of people, not encounters. These are Medicare fee-for-service debridement services: a floor on volume, not a count of irrigations.

Depends on it: Commercial

If it is false: The IWII 2022 consensus does not recommend mechanical irrigation at 4-15 psi. The spray head's pressure specification then has no retrievable clinical source. The 1994 AHCPR guideline it was written against is out of reach (A10 The 1994 AHCPR Clinical Practice Guideline…). The 4-15 psi in intended_use: would then rest only on a predicate submitter quoting that guideline (A27 FDA 510). This is the retrievable source A10 The 1994 AHCPR Clinical Practice Guideline… lacked. Whether it carries A10 The 1994 AHCPR Clinical Practice Guideline…'s dependants is for A10 The 1994 AHCPR Clinical Practice Guideline…'s impact review to decide, not this row.

Depends on it: Clinical & Scientific, Technology & R&D, Regulatory

If it is false: The K210987 summary does not describe 4-15 psi as its predicate's delivered pressure. Then no cleared wound-irrigation summary in the file states the range this kit's intended_use: claims. The 510(k) bench comparison for the three-nozzle head would have no predicate statement of a target, only IRRIGO's "up to 15 psi" ceiling (claim 16verified).

Depends on it: Regulatory, Technology & R&D

If it is false: Experimental low-pressure (asepto syringe) irrigation does cleanse bacterial contaminants as well as high-pressure syringe irrigation does. P0 the original shape claims to beat pouring, soaking or swabbing from an HOCl bottle (A8 Assumption's second comparator) because a pressure-controlled head cleanses better than low-pressure flow. Nothing in the file would then show that. The head's pressure floor would be left with Rodeheaver's 15 psi efficacy figure alone (claim 88verified).

Depends on it: Clinical & Scientific, Commercial

If it is false: The IWII 2022 consensus does not say that hydrogen peroxide, traditional hypochlorite (Dakin's, EUSOL) and chlorhexidine are no longer recommended in open wounds. The kit then loses the one consensus line that separates its irrigant from the CHG in the only cleared closed irrigation kit, IRRISEPT (claim 14verified), and from Dakin's, a cheap hypochlorite that buyers could otherwise treat as equivalent. The line does not cover HOCl. The Verifier's note records that the same document lists HOCl-preserved super-oxidised solutions separately.

Depends on it: Clinical & Scientific, Commercial

If it is false: US wound clinicians do not believe HOCl cleansing beats saline. The label cannot say HOCl acts in the wound (claim 10unconfirmed). The pooled comparative evidence is either unretrieved (A11 "The efficacy of combination of sodium…) or absent: the 2022 systematic review found no eligible HOCl RCT (claim 93verified). So nothing would then give a buyer a reason to pay for the HOCl half of the kit. The kit would compete as a saline irrigation device with a splash shield. At framing this was the proposition that "no claim states". Research has since written it as claim 116unconfirmed, evidence class 3, and it stays unconfirmed unless primary research is attached.

Depends on it: Clinical & Scientific, Commercial

If it is false: The burn-centre cohort did not record HOCl as the initial antiseptic in 11.3% of grafted patients. Then the file holds no observed US clinical use of HOCl at any site, and A30 Stakeholder question has no revealed-behaviour evidence from the US. The study covers one site and burns only.

Depends on it: Clinical & Scientific, Commercial

If it is false: Maragakis et al. did not tie a multidrug-resistant A. baumannii outbreak to pulsatile lavage, with the strain recovered from surfaces in the wound care area. The splash shield then has no documented harm from irrigation spray to point to, and that is what A13 Maragakis LL et al. was registered for. This restatement drops the two details claim 47unconfirmed could not support. The outbreak was pulsatile lavage, not 4-15 psi irrigation. It shows that irrigation spray can cause harm. It does not show that this kit's spray is a comparable hazard.

Depends on it: Clinical & Scientific, Operations & NPI, Commercial

If it is false: The 1993 beef-wound study did not find less face-and-chest splatter with Irrijet or Zerowet shields than with a bare angiocatheter. The splash-shield differentiator then has no measurement anywhere in the file; claim 49unconfirmed had disclosed none. The "better working environment" half of the proposition would then rest on the referrer's description alone (claim 1unconfirmed). The study used syringe irrigation and existing shields. It did not test this kit's shield.

Depends on it: Commercial, Operations & NPI, Clinical & Scientific

If it is false: Spraying the kit's HOCl through three nozzles may produce a clinician inhalation exposure that matters: an oxidant aerosol, or chlorine released at acidic pH. If it does, the "better working environment" proposition inverts, because the shield sits in the user's breathing zone. Exposure data become part of the 510(k) and of the OSHA case (claim 48verified), and the shield or nozzle design may have to change. The candidate's design note says this claim is "on the register", but it was left out at framing. It is registered now, with the tag visible.

Depends on it: Operations & NPI, Regulatory, Commercial

If it is false: The 2024 study did not find "no analogous damage" in fibroblasts exposed to aerosolised HOCl from a 300 ppm solution for 3 minutes. That is the only exposure datum in the file near the kit's working concentration; Vashe is 150-330 ppm AFC (claim 4verified). A34 Open safety question would then have no measurement on either side. The same study found cytotoxicity after four 9-minute exposures at 500 ppm. It used dry fog on cultured cells, so it applies to the kit by analogy only.

Depends on it: Operations & NPI, Clinical & Scientific

If it is false: Spraying sodium hypochlorite did not keep chlorine gas below detection limits in the controlled study. Then the one measurement in the file on whether spraying a hypochlorite solution releases chlorine is gone. A34 Open safety question's chlorine-release concern would have nothing against it. The study was surface disinfection with NaOCl, so it applies by analogy only.

Depends on it: Operations & NPI, Regulatory

If it is false: A threat row, like A37 FTO field lead. Suppose a live claim of US 10,391,207 (irrigation fluid containment systems) reads on a splash shield or containment around a wound-irrigation stream. Then the shield needs a licence or a design-around before US sale. The term is open. INPADOC gives a naive 2037, but the priority chain back to a 2004 non-provisional may mean it ended about 2024. So the first thing to settle is which date applies, before anyone reads its claims.

Depends on it: Legal & IP, Operations & NPI

If it is false: Suppose either US member of PuriCore's WO 2008/040020 family is not abandoned, or a member INPADOC does not link survives. Then the closest lead in the file to the kit's own concept is live: an HOCl solution plus a wound-delivery apparatus, from the company that originated Vashe. FTO for the combination, not just the solution (A15 FTO, solution: US 8,871,278, "Stabilized…) or the hardware (A16 FTO, device: US 8,002,757, "Splash shield…), would then turn on its claims. INPADOC last exchanged this record in 2019.

Depends on it: Legal & IP, Technology & R&D

If it is false: A threat row, like A37 FTO field lead. Suppose a live claim of Sonoma's US 10,342,825 ("Solution containing hypochlorous acid and methods of using same", naive term to 2030) reads on the kit's HOCl-preserved saline. Then the solution half needs a licence, licensed supply or a formulation design-around until about 2030. That is the consequence A15 FTO, solution: US 8,871,278, "Stabilized… carries for the Urgo family, from a second holder. The other three patents in the claim are peritonitis, inflammation and hypersensitivity methods. Their terms may end about 2027 if their 2007 priority claims are benefit claims.

Depends on it: Legal & IP, Commercial

If it is false: Sonoma's 10-K does not state that Microdacyn60 Wound Care is Class IIb under the MDR. A17 Generator's belief's IIb reading then loses its second statement of an MDR IIb HOCl wound solution; the press-release version is claim 22unconfirmed. The precedent the EU route is planned against is then unestablished. The 10-K is a company statement, not a notified-body certificate. The claim is held unconfirmed because it is an EU claim, not because of anything the check found.

Depends on it: Regulatory (EU), Commercial (DK)

If it is false: The Region Nordjylland joint wound tender does not buy HOCl wound irrigation fluid as a lot of its own (lot 50), separate from non-HOCl irrigation fluid (lot 49) and NaCl (lot 53). Then the only counter-evidence to A18 Assumption is gone, and in the referrer's home market the kit meets sterile NaCl in the same lot at commodity price. If the claim is true, it has a second side. Lot 50 is a 48-month contract, and its winner was not established: the award notice's tenderers include Mölnlycke (claim 115unconfirmed), and Mölnlycke owns Granudacyn's maker (claim 110verified). Whoever holds lot 50 holds Nordjylland's HOCl irrigation business for the contract term. The claim is held unconfirmed because it is a DK claim, not because of anything the check found.

Depends on it: Commercial (DK), Market Access

If it is false: The proposed rule does not put HOCl in its low-level AMR concern tier. Then A4 Generator's belief's worst case comes back. Once the rule is finalized, an HOCl wound wash may land in a tier FDA proposes to classify as Class III. The FRO 510(k) launch route then closes and a PMA replaces it, and the P0 the original shape calendar and capital do not fit. This is the tier reading that A4 Generator's belief's claim 12verified recorded as unread.

Depends on it: Regulatory (C2, bound); Commercial

If it is false: FDA's proposal does not say that delivering antimicrobials to the wound may fall outside CDRH, or does not map wound-treatment claims to the Class III codes MGR or MDD. Then Regulatory's cost for the "HOCl as antimicrobial" rungs loses its FDA source: a drug or combination programme for rung 2, a PMA for rung 3. A43 Proposed rule FR Doc 2023-26209's consequence also changes. If HOCl can no longer be called a preservative, nobody knows where its other reading lands; this row is the only basis for saying it leaves the device route. This is the FDA text that claims 10 and 20 lacked. At framing those two were left off the register, because their falsity only makes the antimicrobial claim cheaper. A chair has now bound the FDA statement under them, and a binding outranks that exclusion.

Depends on it: Regulatory (C3, bound); Clinical & Scientific (REQ-0219 What adequate and well-controlled clinical… prices rung 2 in evidence)

If it is false: K232080 is not labelled for multiple use within a single patient. Then the way out of A43 Proposed rule FR Doc 2023-26209 that Regulatory calls cheapest has no cleared HOCl precedent to copy. A per-patient bag would be a new configuration, needing its own in-use stability and preservative-effectiveness case. If A43 Proposed rule FR Doc 2023-26209 is also true, sterile saline with no HOCl is the only low-burden shape left in Regulatory's field. Twin: A49 FDA 510, the same summary read by Operations & NPI for different facts.

Depends on it: Regulatory (C4, bound); Commercial (REQ-0220 Does the closed-kit consumable pull-through…, answered in its position); Technology & R&D (REQ-0218 Can an HOCl-preserved saline irrigation bag…)

If it is false: Irrisept K240552 is not built as two separately sterilized sub-assemblies joined at the point of use. Then the one architecture Operations & NPI says P0 the original shape can be made on today has no precedent in the only cleared self-contained antiseptic irrigation kit. What is left is the pre-connected, wetted assembly sterilized as one. Operations moves toward blocks on that version until shelf-life materials data exist. Twins: A47 The FDA 510 (the same summary, Regulatory's reading) and A68 FDA has cleared antiseptic wound-irrigation… (the same architecture, from K080779 and K253445).

Depends on it: Operations & NPI (C1, bound); Technology & R&D (its connect-at-use reading, A68 FDA has cleared antiseptic wound-irrigation…)

If it is false: The K232080 summary does not show sterile HOCl in foil-pouched flexible LLDPE bags, backed by ICH stability, USP 51 and ISO 11607 testing. Then the feasibility precedent for the hardest half of the kit, sterile HOCl in a bag, is gone. A3 FDA 510's bag-format precedent becomes a product listing with no test basis anyone can follow. The claim's second half points the other way. If the summary does name its sterilization method, a new entrant learns which process works, and P0 the original shape gets easier. Twins: A3 FDA 510 and A46 The FDA 510.

Depends on it: Operations & NPI (C2, bound); Technology & R&D

If it is false: HOCl-preserved saline in a flexible bag cannot be labelled for room-temperature storage through its shelf life. Then the kit needs cool or cold-chain storage. That changes distribution cost, and it breaks the stock-on-the-shelf consumable model P0 the original shape assumes in every setting, home health included. The heat-stability findings (claims 96-97), listed under A14 Open design question, point this way. This row is about shelf storage. A14 Open design question is about warming at the point of use.

Depends on it: Operations & NPI (C3, bound); Technology & R&D (item 2: real-time stability is the long pole)

If it is false: Some HOCl-wetted part of the kit consumes free chlorine, fails USP 51 or sheds metal ions over its shelf life. Then the preservative fails in the product, the failure recall Z-0890-2013 records (claim 72unconfirmed). The 510(k) stability section fails, and the part has to be redesigned and the stability clock restarted. A head stored pre-connected and wetted is inside this row in full. Twins: A71 The kit's fluid path from bag port to… (Technology's C5, the same fluid path) and the materials half of A14 Open design question.

Depends on it: Operations & NPI (C4, bound); Technology & R&D; Regulatory (the stability and biocompatibility data a 510(k) needs)

If it is false: Fewer than two independent fillers can supply sterile HOCl in bags, counting only fillers that do not sell HOCl wound cleansers in the US themselves. Then the hardest half of the kit is sole-sourced, probably from a competitor, or the programme builds HOCl generation and sterile filling itself. Either way P0 the original shape moves toward neighbouring shape (c) because it has to, not because anyone chose it, and every kit inherits its filler's recalls. Read with A73 Independent claim 1 of US 8,871,278 B2 and A74 Independent claim 1 of US 10,342,825 B2: an independent filler's formulation still faces the Urgo and Sonoma claims. A licensed incumbent's would not.

Depends on it: Operations & NPI (C5, bound); Commercial

If it is false: The VA FSS entry for V797D-50441 gives no per-unit Vashe price with a fill volume. Then the upper edge of the band the kit must price inside stays one retailer's list price on one day (A23 Price observation for claim 37), and neither side of A8 Assumption has a contract price.

Depends on it: Commercial (C3, bound)

If it is false: Lot 50 in Region Nordjylland awards on price alone. Lot 50 is the one Danish tender lot that exists for HOCl irrigation. The kit's hardware differentiation (closed, pressure-ranged, shielded) then earns nothing in its award, and A18 Assumption's commodity reading holds for that lot. Twins: A18 Assumption (claim 26unconfirmed), A42 Revealed-behaviour twin for claims 25-26 (claim 113unconfirmed) and claim 118unconfirmed.

Depends on it: Commercial (C4, bound); Market Access (DK)

If it is false: Lot 50's specification does not accept HOCl fluid co-packaged with an applicator and shield as one product. Then the kit cannot bid into the only Danish HOCl lot as a kit, and its hardware half has no priced home in that tender. The Danish route waits for a re-tender or a new lot. Twin: A62 A co-packaged HOCl wound irrigation kit (Market Access C3), in effect the same proposition.

Depends on it: Commercial (C5, bound); Market Access (DK)

If it is false: A threat row on timing. If the claim is false, the award notice names no lot-50 winner or no 48-month term. The Danish timing is then unknown rather than known to be late, and nothing in P0 the original shape breaks. If the claim is true, a named supplier holds Nordjylland's HOCl irrigation business until about 2029, possibly a Mölnlycke company (A42 Revealed-behaviour twin for claims 25-26). The referrer's home market then has a dated wait before first revenue.

Depends on it: Commercial (C6, bound); Market Access (DK)

If it is false: No notified body has certified an HOCl wound irrigation solution as Class IIb under Rule 4 with HOCl as a preservative. Then the EU planning case is Class III under Rule 14, with a medicinal-substance consultation and a heavier clinical evaluation. The referrer's Danish home market moves from a precedented IIb route to a Class III programme. Twins: A17 Generator's belief (claim 21unconfirmed) and A41 Bears on claim 22 with an SEC filing rather… (claim 112unconfirmed). Expected back unconfirmed, because no connector reaches notified-body certificates.

Depends on it: Regulatory (C6, bound, EU); Commercial (DK)

If it is false: No RCT of at least 100 chronic-wound patients has shown HOCl cleansing beating saline, water or placebo on complete healing at 12 weeks or later. Then the HOCl half of the kit has no healing result under it, and a buyer pays for it on belief (A30 Stakeholder question) and surrogate endpoints. Under P0 the original shape's label the result could not be claimed anyway (claim 10unconfirmed). Clinical expects this claim to come back false. A refuted or unconfirmed tag here confirms the chair's prediction, and it bears on the referrer's question (HOCl or water?) more than on P0 the original shape's label. Read with A43 Proposed rule FR Doc 2023-26209, it is where HOCl may have neither a claimable clinical role nor a preservative one (REQ-0205 Would FDA accept HOCl described as a…). Twins: A11 "The efficacy of combination of sodium… (claim 44unconfirmed), A30 Stakeholder question (claim 116unconfirmed) and claim 93verified.

Depends on it: Clinical & Scientific (C3, bound); Commercial

If it is false: NCT07440797 is not as registered: it is not randomized, or not Vashe against saline, or its size or endpoint differs, or it is already recruiting or reporting. Then Clinical's timing has no record under it. Clinical names this readout, perhaps two years away, as the event most likely to move clinician belief. If results are already posted, the evidence under A30 Stakeholder question has moved and nobody here has read it.

Depends on it: Clinical & Scientific (C4, bound); Commercial

If it is false: FDA has not cleared an antiseptic irrigation system supplied as a container plus an applicator in one package and joined at the point of use. Then connect-at-use has no clearance precedent. Integration becomes a development item whichever configuration is chosen. And the sterilization and shelf-life materials problems of a pre-connected assembly cannot be designed out by copying a cleared kit. Twin: A48 FDA 510.

Depends on it: Technology & R&D (C2, bound); Operations & NPI (its C1 reading, A48 FDA 510)

If it is false: The kit's head, fed by its own pressurisation means, does not hold 4-15 psi at its working distance from the first 10% of the bag to the last. Then the device misses the performance clause in its own intended_use:, the 510(k) bench comparison with K210987 (IRRIGO) fails, and production tooling cannot be frozen. Twins: A10 The 1994 AHCPR Clinical Practice Guideline…, A26 Bears on claim 40 with a retrievable source and A27 FDA 510. Those rows say where the 4-15 psi target comes from; this row says whether the kit hits it. A10 The 1994 AHCPR Clinical Practice Guideline…'s review must not let a verified source stand in for a delivery nobody has measured. Expected back unconfirmed until a prototype is tested.

Depends on it: Technology & R&D (C3, bound); Clinical & Scientific (the bench step before A63 In a single-session clinical-use study in…, REQ-0203 For the P0 three-nozzle head fed from the…); Regulatory (the 510(k) bench comparison); Operations & NPI (tooling freeze)

If it is false: Metal touches the solution somewhere between the bag port and the nozzle exit. Or solution held in that path for the longest contact the configuration allows drifts out of free-chlorine specification. Then the head repeats recall Z-2275-2026, a sprayer spring corroded by HOCl (claim 71unconfirmed). The wetted path is redesigned before tooling, and a pre-connected configuration fails outright. Twin: A51 Every HOCl-wetted material in the kit, the same path as Operations & NPI specifies it, with USP 51 and metals tests.

Depends on it: Technology & R&D (C5, bound); Operations & NPI

If it is false: Emptying a full bag inside the shield at maximum pressure puts airborne chlorine in the operator's breathing zone above the OSHA ceiling in 29 CFR 1910.1000 Table Z-1. Then the shield gathers an above-limit exposure at face height, and the working-environment proposition reverses. The kit cannot be used without respiratory controls, and the shield and nozzles are redesigned before tooling. Twins: A34 Open safety question (claim 51unconfirmed), A35 Bears on claim 51 and A36 Bears on claim 51 by analogy only (the analogies), and A64 In simulated or clinical use (Clinical's stricter pass mark).

Depends on it: Technology & R&D (C6, bound); Operations & NPI (owns what the exposure means for staff); Clinical & Scientific (A64 In simulated or clinical use); Commercial

If it is false: Independent claim 1unconfirmed of US 8,871,278 is broader than an added-DIC solution in a gas-barrier container. Then A15 FTO, solution: US 8,871,278, "Stabilized…'s exposure widens, because HOCl saline without an added stabiliser may sit inside Urgo's claim. The solution half needs a licence, licensed supply or a design-around, which pushes toward shape (c). A52 Sterile HOCl wound-irrigation solution…'s independent filler then becomes an FTO problem as well as a supply one. Twin: A15 FTO, solution: US 8,871,278, "Stabilized… (claim 52verified).

Depends on it: Legal & IP (C1, bound); Technology & R&D (REQ-0223 Specify the P0 kit's solution and hardware…, the formulation spec); Operations & NPI (A52 Sterile HOCl wound-irrigation solution…)

If it is false: Independent claim 1unconfirmed of US 10,342,825 is broader than pH 5.6, very low chloride and a phosphate buffer. Then A40 Bears on claim 53's exposure widens to saline-based HOCl until about 2030, and the solution needs a licence, licensed supply or a formulation design-around. Twin: A40 Bears on claim 53 (claim 85verified).

Depends on it: Legal & IP (C2, bound); Technology & R&D

If it is false: US 8,002,757 is still in force. Then the base Schultz shield patent is live alongside its continuations, to about 2027 on INPADOC's naive term, and A16 FTO, device: US 8,002,757, "Splash shield…'s exposure includes it. Twin: A16 FTO, device: US 8,002,757, "Splash shield… (claim 56verified).

Depends on it: Legal & IP (C3, bound); Technology & R&D

If it is false: At least one of US 8,672,904, 11,083,835 and 12,208,226 has a term running past 2032. Then A16 FTO, device: US 8,002,757, "Splash shield…'s hardware exposure runs toward INPADOC's naive 2041, past any plausible launch, and a shield licence or design-around becomes a launch item rather than a wait. Twin: A16 FTO, device: US 8,002,757, "Splash shield…. Legal names this term check as the cheapest move in its field.

Depends on it: Legal & IP (C4, bound); Technology & R&D; Commercial

If it is false: Some independent claim of CareFusion's US 12,178,977 does not recite a warming component. Then dropping warming does not take the kit out of a family that runs to about 2041, though three chairs name dropping it as a simplification. A37 FTO field lead's threat reaches the unwarmed kit too. Twin: A37 FTO field lead (claim 80verified).

Depends on it: Legal & IP (C6, bound); Technology & R&D (its "drop warming" pivot rests on it)

If it is false: An in-force US patent or published application outside the named families claims one of three things: a bag-fed multi-nozzle wound spray head, a shield integral with one, or an HOCl-plus-applicator kit. Then FTO is blocked, on the hardware half or on the combination, by a holder nobody has named, until a licence or a design-around exists. That is the input to the rubric's automatic kill. The landscape has not been run (REQ-0212 Run a recorded), so this is expected back unconfirmed. It is claim 58unconfirmed's unexamined field, now stated as a proposition.

Depends on it: Legal & IP (C7, bound); Technology & R&D; Commercial

If it is false: A threat row, like A37 FTO field lead. If the claim is false, both leads have lapsed. They close, and nothing breaks. The row is here for the other direction. If the claim is true, US 12,642,907 (to about 2044) and US 10,568,785 (to about 2036) are live leads on wound-washing hardware whose claims nobody has read. The head and shield then have two more possible holders to clear.

Depends on it: Legal & IP (C8, bound); Technology & R&D

If it is false: WO 2008/040020 does not disclose an apparatus for delivering HOCl to a wound. Then Legal's reading that nobody can own the HOCl-plus-applicator concept loses its earliest document, and more of the combination may be patentable. This is patentability, not FTO. If the claim is false, P0 the original shape gains something it could own, and nothing breaks. Registered because it is bound. Twin: A39 FTO field lead closed (claim 83verified).

Depends on it: Legal & IP (C9, bound); Commercial (defensibility)

If it is false: An EP patent in force in Denmark, or a pending EP application, claims the head, an integral shield, the HOCl solution or the kit. Then the referrer's home market has an FTO block that the US work says nothing about. The nearest lead is the Heraeus applications EP4806473A1-76A1 (2026-09). Expected back unconfirmed, because no connector tags a non-US patent.

Depends on it: Legal & IP (C11, bound, EU/DK); Commercial (DK)

If it is false: If false, the proposed rule does not limit antimicrobial preservatives to nonsterile or multiple-use single-patient washes. Then the P1 per-patient HOCl bag bag loses the text that places it inside proposed 878.4019(a)(1). The reason P1 per-patient HOCl bag moved from a single-use bag to a per-patient bag, and took on an in-use stability and preservative-effectiveness programme (A102, A103), has no regulatory basis, and the single-use bag returns as a lower-burden option the record set aside. A separate event, not this claim being false: Regulatory moves toward blocks if a final rule narrows (a)(1) to exclude sterile multiple-use washes. claim 12verified (A4 Generator's belief) is where finalization would show. A43 Proposed rule FR Doc 2023-26209 is this claim's P0 the original shape row, read as a threat. This row is the same claim read as something P1 per-patient HOCl bag rests on. Registered with the tag visible.

Depends on it: Regulatory (C1, bound, re-stated against P1 per-patient HOCl bag); Clinical & Scientific (its verdict reads the bag's preservative job from this claim and claim 122verified); Commercial (the bag's one job on the label)

If it is false: If false, a hand-squeezed flexible bag reaches 4-15 psi on its own, and P1 per-patient HOCl bag's squeeze chamber and check valves are not needed. The head shrinks back to nozzles and a shield, with fewer parts, fewer tests (A118) and a lower unit cost (A114). Nothing in P1 per-patient HOCl bag breaks; it gets simpler. Registered because it is bound, and because it is the stated reason for P1 per-patient HOCl bag's mechanism:. A67 Published bench measurement is the same claim read as a threat to P0 the original shape's mechanism:. Registered with the tag visible.

Depends on it: Technology & R&D (C1, bound); Operations & NPI (the valved head assembly and its tests exist because of it); Commercial (the head's added hardware cost)

If it is false: If false, US facilities and agencies pay no more per session for one P1 per-patient HOCl bag head plus a share of a bag than for saline and a syringe, or an HOCl bottle. The head is P1 per-patient HOCl bag's only per-irrigation revenue, so it is then priced as a commodity accessory, and the per-session margin rests on nothing. Successor to A8 Assumption (claim 62unconfirmed, the P0 the original shape kit). Twin: claim 117unconfirmed. Evidence class 3: no connector reaches buyer behaviour, so it is expected back unconfirmed.

Depends on it: Commercial (C2, bound: the revenue premise of P1 per-patient HOCl bag); Market Access (the bundle sets the ceiling any premium must fit under); Operations & NPI (C6's per-session price, A114)

If it is false: P1 per-patient HOCl bag-b, now a claim. If false, buyers refuse a head that fits only its own maker's bag, or require one that fits the spike ports of bags they already stock. Then the bag is not pulled through. The head is sold for any bag, which is neighbouring shape (a), and the bag has to win alone as a parity HOCl solution. The reason P1 per-patient HOCl bag keeps the head single-use and keyed is gone. Evidence class 3, expected back unconfirmed.

Depends on it: Commercial (C3, bound); Operations & NPI (keying makes the bag a custom part a filler must accept, A52 Sterile HOCl wound-irrigation solution…); Technology & R&D (keying and reclosure sit on one connector, A94 The per-patient bag's access port accepts a…)

If it is false: If false, the usual interval between visits in a US outpatient wound clinic is longer than the in-use period labelled on the cleared HOCl bag. In that setting each session then costs a head plus a whole bag. That is P0 the original shape's economics with the waste shown, in the setting where most Medicare FFS selective debridement happens. Checkable from two public retrievals (REQ-0228 Retrieve the labelled storage condition, and a published US visit interval). Twin: A115 (claim 189unconfirmed).

Depends on it: Commercial (C4, bound); Operations & NPI (its C8, A115, is the four-setting version); Market Access (where the bag sits between visits decides its payer, A92 Medicare Part B makes no payment for a…)

If it is false: If false, 414.22(b)(5) does not split practice expense into facility and nonfacility RVUs as stated. Then Market Access's reading of who buys in an outpatient wound clinic (the hospital in a hospital-based clinic, the practice in an office-based one) loses its regulation text, and the clinic's buyer goes back to unstated. Market Access says falsity here clarifies or gains a line rather than losing a route. Registered because it is bound.

Depends on it: Market Access (C4, bound); Commercial

If it is false: If false, CMS's CY 2026 practice-expense inputs list no irrigation supply for 97597 in the office setting. The office still buys the product, but out of practice expense CMS never itemised for irrigation. P1 per-patient HOCl bag then displaces an unpriced line rather than a known saline-and-syringe cost. Nothing in P1 per-patient HOCl bag breaks; the comparator price becomes less visible. Registered because it is bound. Expected back unconfirmed while no connector reads the input files.

Depends on it: Market Access (C5, bound); Commercial (the cost-in-use comparison)

If it is false: A threat row. If false, some Part B benefit pays for an A6260 wound cleanser dispensed for home use between clinic visits. A bag that goes home then gains a payer, and nothing breaks. The row is here for the other direction. If true, a P1 per-patient HOCl bag bag that leaves the clinic with an outpatient leaves both provider budgets, and the patient, or a non-Medicare plan if one pays (REQ-0202 Outside Medicare), pays for it. Bad news here arrives as verified, which fires no review.

Depends on it: Market Access (C8, bound); Commercial (C4's outpatient reading); Operations & NPI (REQ-0235 For the P1 per-patient HOCl bag, where the opened bag sits)

If it is false: P1 per-patient HOCl bag-a, now a claim (Technology's form). If false, the HOCl-preserved saline in the per-patient bag drifts out of its FAC or pH specification, or fails USP <51>, within its in-use period, on fresh or end-of-shelf-life bags. Then the bag cannot carry a multiple-use label. The proposed rule leaves a preserved wash two configurations, nonsterile or this one (claim 119verified), so P1 per-patient HOCl bag's bag has no clearable labelling. Technology and Regulatory both say they move to blocks on the bag. Twins: A103 (claim 177unconfirmed, the same premise in Regulatory's three-lot form), A94 The per-patient bag's access port accepts a… (claim 168unconfirmed, the port), A100 (claim 174unconfirmed, wound organisms at the port) and A115 (claim 189unconfirmed, the period against the session interval). Needs a built bag, so expected back unconfirmed.

Depends on it: Technology & R&D (C7, bound); Regulatory (its twin, A103, is what its verdict turns on); Operations & NPI (C8, A115); Clinical & Scientific (the bag must stay clean across reuse, A100); Commercial (the bag spread over sessions)

If it is false: If false, the bag's port does not reclose when the head is removed, fails a container-closure or microbial-ingress challenge after the maximum connect-and-disconnect cycles, or has metal in its wetted path. Then an opened bag is open to air and organisms between sessions, and P1 per-patient HOCl bag-a (A93 The system's hypochlorous acid-preserved…) fails for a mechanical reason. A metal part would repeat recall Z-2275-2026 (claim 71unconfirmed) on the part with the longest HOCl contact in the system. The keyed connector P1 per-patient HOCl bag-b (A88 US facility and agency purchasers) needs sits on this same interface, so a redesign here restarts both. Twin of P1 per-patient HOCl bag-a.

Depends on it: Technology & R&D (C8, bound); Operations & NPI (the re-entry part joins the bag's bill of materials); Clinical & Scientific (the port is the ingress route its C7 challenges)

If it is false: If false, K251757 does not show an aseptically made, foil-pouched HOCl bag labelled for multiple use within one patient and tested feeding separate jet-lavage hardware. Then P1 per-patient HOCl bag's bag loses its nearest model, an aseptically filled HOCl bag feeding hardware that is not its own, and Operations' aseptic-fill planning case loses its precedent. A49 FDA 510 (claim 125verified) remains as the sterile-bag precedent, with no named process.

Depends on it: Technology & R&D (C9, bound); Operations & NPI (its aseptic-fill planning case); Legal & IP (the precedent's formulation, for REQ-0223 Specify the P0 kit's solution and hardware…)

If it is false: If false, an HOCl irrigation bag offered alone is not a conforming offer under lot 50. Then Danish public money for HOCl irrigation in Region Nordjylland reaches neither half of P1 per-patient HOCl bag through any existing lot, and the Danish route waits for a re-tender or a new lot. Successor to A62 A co-packaged HOCl wound irrigation kit (claim 138unconfirmed, the co-packaged P0 the original shape offer). Expected back unconfirmed while no connector serves DK.

Depends on it: Market Access (C6, bound, DK); Commercial (DK)

If it is false: If false, no lot in the Nordjylland tender admits a spray head with an integral shield offered without fluid. The P1 per-patient HOCl bag head, P1 per-patient HOCl bag's only per-session revenue, then has no public-money route in that region until a re-tender creates one, even if the bag wins lot 50. Twin: A57 The technical specification of lot 50 (claim 133unconfirmed, the head offered with the fluid). Expected back unconfirmed.

Depends on it: Market Access (C7, bound, DK); Commercial (DK: whether the head has a priced home in the tender)

If it is false: If false, in clinicians' hands the P1 per-patient HOCl bag head does not hold 4-15 psi for every operator, including at maximal grip, or it removes less slough and debris than a 35 mL syringe with a 19G angiocatheter. Then the performance clause in intended_use: is a property of the hand, not the device, and P1 per-patient HOCl bag is worse than its cheapest comparator at the one thing its label claims. Successor to A63 In a single-session clinical-use study in… (claim 139unconfirmed, the P0 the original shape kit). Twins: A69 The kit's three-nozzle head (claim 145unconfirmed, the bench version), and A26 Bears on claim 40 with a retrievable source and A27 FDA 510 (where the target comes from). Needs a built head, so expected back unconfirmed.

Depends on it: Clinical & Scientific (C5, bound); Technology & R&D; Regulatory (its C11 names this the in-hand version of claim 145unconfirmed); Commercial

If it is false: If false, the P1 per-patient HOCl bag shield, driven at maximal grip, does not reduce splatter on the irrigator against an unshielded syringe, or breathing-zone chlorine is detectable. "Better working environment", which Clinical calls the one advantage P1 per-patient HOCl bag can put on its label as its own, then has no measurement under it, or it reverses. Successor to A64 In simulated or clinical use (claim 140unconfirmed). Twins: A117 (claim 191unconfirmed, Operations' pass mark), A72 During simulated wound irrigation with the… (claim 148unconfirmed, Technology's) and A34 Open safety question (claim 51unconfirmed). The pass marks still differ: this row says below detection, and A117 says at or below 1 ppm.

Depends on it: Clinical & Scientific (C6, bound); Operations & NPI; Commercial (its staff-protection positioning)

If it is false: If false, S. aureus, P. aeruginosa or A. baumannii introduced at the port in a protein soil survive in a repeatedly spiked bag to the end of its in-use period, or FAC leaves specification. Then the per-patient bag carries a contamination hazard the single-use P0 the original shape bag did not have, and Clinical moves toward blocks on the multiple-use bag. It is the one clinical-safety question P1 per-patient HOCl bag created. Twin of P1 per-patient HOCl bag-a (A93 The system's hypochlorous acid-preserved…). USP <51> does not test it.

Depends on it: Clinical & Scientific (C7, bound: the result its verdict moves on); Technology & R&D (owns the method); Regulatory (REQ-0240 For a sterile HOCl-preserved wound wash in… asks whether this is a clearance requirement); Operations & NPI (the in-use regimen)

If it is false: If false, the randomized evidence on warmed against room-temperature saline irrigation shows an outcome difference, not only comfort. Then P1 per-patient HOCl bag's room-temperature irrigant carries a clinical cost nobody has priced, and the decision to drop warming loses its clinical footing. Bringing warming back would also bring back the HOCl heat-stability findings (claims 96 and 97) and the CareFusion warming family (A78 Every independent claim of US 12,178,977 B2, A113). Neither trial is in chronic wounds.

Depends on it: Clinical & Scientific (C8, bound: its answer to REQ-0210 Is warming the irrigant to about body…); Technology & R&D, Legal & IP and Operations & NPI (each named dropping warming)

If it is false: If false, proposed 878.4019(b)(2) does not require continued low bioburden, stability and preservative effectiveness over the use life, tested on three real-time-aged lots under worst-case simulated use. The P1 per-patient HOCl bag bag's evidence burden would then be lighter than Regulatory prices it, and nothing breaks. Registered because it is bound, and because it sets the test A103 must pass.

Depends on it: Regulatory (C6, bound: the evidence package the bag is priced against); Technology & R&D and Operations & NPI (the in-use study's design and calendar)

If it is false: P1 per-patient HOCl bag-a, now a claim (Regulatory's form). If false, solution from three lots aged to the end of shelf life, then put through worst-case simulated use over the labelled in-use period, leaves its FAC or pH specification or fails USP <51>. Then the bag cannot carry a multiple-use label, and Regulatory moves to blocks on P1 per-patient HOCl bag's bag, because the proposed rule leaves a preserved wash only nonsterile or this configuration (claim 119verified). Its calendar stacks on shelf life: on Technology's arithmetic, more than 13 months from the first filled batch at the 12-month precedent. Twin: A93 The system's hypochlorous acid-preserved… (claim 167unconfirmed); also A94 The per-patient bag's access port accepts a…, A100 and A115. Needs a built bag, so expected back unconfirmed.

Depends on it: Regulatory (C7, bound: what its verdict turns on); Technology & R&D; Operations & NPI; Clinical & Scientific

If it is false: If false, the K253665 summary does not show USP <51> on aged samples through a simulated 7-day multi-use period, spike-adapter compatibility testing, a GLP porcine study, and no clinical data. Then the most recent HOCl multi-use precedent no longer sets the bag's evidence floor at bench plus an animal study with no clinical data. Regulatory's answer to REQ-0204 Could an FRO 510, that clearance needs no clinical data on precedent, loses half its basis.

Depends on it: Regulatory (C8, bound; its answer to REQ-0204 Could an FRO 510 rests on it); Operations & NPI (the vented spike adapter as a re-entry precedent); Clinical & Scientific (whether its studies are regulatory)

If it is false: If false, the IRRIGO summary does not rest on bench, pressure, sterilization and biocompatibility testing with no clinical testing. Then the hand-squeezed head's evidence floor is unknown, and a clinical study such as A98 In a single-session clinical-use study in…'s may be a clearance requirement for the head, not only an adoption one.

Depends on it: Regulatory (C9, bound); Clinical & Scientific (REQ-0204 Could an FRO 510)

If it is false: If false, FDA would not place the P1 per-patient HOCl bag head in 880.5475 or 880.6960, and its route is a De Novo. The head then needs a new classification, with its own special controls and calendar. The schedule in A120 slips, and Regulatory blocks the head as framed. Only FDA can settle this, through a 513(g) request or a Pre-Submission, and either one discloses the opportunity outside the organisation, which is a human decision. Expected back unconfirmed.

Depends on it: Regulatory (C10, bound; moves to blocks for the head as framed if false); Operations & NPI (C12's schedule assumes this route, A120); Legal & IP (its launch-date trigger)

If it is false: A threat row. If false, the real independent claims of US 11,083,835 and 12,208,226 are not as described, and the Schultz question changes size in a direction this file cannot predict. The row is here for the other direction. If true, five independent claims recite a fluid or irrigation source connector, a nozzle and a shield, not a bottle or a syringe. Reading them against a defined P1 per-patient HOCl bag head is then counsel's work, needed before any US launch inside the term window: about 2032-04 on A76 US 8,672,904 B1, later if A108 or A109 says so. Successor to A77 Independent claim 19 of US 11,083,835 B2 (claim 153refuted). Per IR-34 claim 153 came back refuted there is no second commission: a refuted here is a finding. Bad news arrives as verified.

Depends on it: Legal & IP (C5, rebound per IR-34 claim 153 came back refuted; part of its named blocks trigger); Technology & R&D (REQ-0249 For the P1 head assembly, the head geometry); Operations & NPI (REQ-0250 What is the earliest plausible date the P1…, the launch date)

If it is false: If false, US 10,363,356's 2000 benefit claim does not count, its term runs from 2010-08-05, and it ends about 2033-05-15. The Schultz utility window then runs about a year past the 2032-04 that IR-34 claim 153 came back refuted and A120 use, and a US head launch before 2033-05 needs counsel's read or a design-around.

Depends on it: Legal & IP (C14, bound); Operations & NPI (A120's date)

If it is false: A threat row. If false, the Schultz design patents are bounded by the family's utility terms, and the window closes with them. The row is here for the other direction. If true, D956,963 and D1,085,409 each run 15 years from their own grant, past 2032. The Schultz family then has a design-right clock on an ornamental shield design nobody here has compared with the P1 per-patient HOCl bag shield, and launching after 2032-04 no longer clears the shield by itself. Bad news arrives as verified.

Depends on it: Legal & IP (C15, bound; part of its named blocks trigger)

If it is false: If false, US 12,642,907's only independent claim does not require a battery and a battery-driven pump. The nearest manual-gun lead (to about 2044, A80 US 12,642,907 B2) then stands as wide as its title, "manual and battery powered", and may reach a hand-pressurised P1 per-patient HOCl bag head. That is a hardware FTO question running to about 2044, which P1 per-patient HOCl bag's no-pump design was assumed to avoid.

Depends on it: Legal & IP (C16, bound); Technology & R&D (P1 per-patient HOCl bag excludes a pump)

If it is false: If false on the limitations, Medaxis's independent claims are wider than a flexible, fluid-tight cover with a stiffening element and a transparent plate, and the P1 per-patient HOCl bag shield faces a broader second holder. If false on the term, the window is shorter than computed. Either way the shield's clearance date moves. If true, Medaxis's US 10,568,785 is a second shield holder to about 2038-09-30, six years past the Schultz window, with specific limitations for counsel to test against REQ-0249 For the P1 head assembly's geometry.

Depends on it: Legal & IP (C17, bound; part of its named blocks trigger); Technology & R&D (REQ-0249 For the P1 head assembly)

If it is false: A threat row, like A80 US 12,642,907 B2. If false, the two leads have lapsed, and nothing breaks. If true, US 10,398,811 (to about 2037) and US 11,504,457 (to about 2040) are two more in-force wound-irrigation patents whose claims nobody has read, and they show that the earlier sweeps under-reached. Bad news arrives as verified.

Depends on it: Legal & IP (C18, bound); Technology & R&D

If it is false: A threat row. If false, neither CareFusion application is pending, and the warming family closes for P1 per-patient HOCl bag with its grant (A78 Every independent claim of US 12,178,977 B2). If true, the continuation US 2025/0082838 and the flow-interface application US 2025/0375566 are pending and unread. Either could issue with claims that do not recite warming and that read on an unwarmed, bag-fed head. This is what is left of A37 FTO field lead's exposure once P1 per-patient HOCl bag dropped warming. Read with A78 Every independent claim of US 12,178,977 B2 (claim 154verified), which takes the grant out of P1 per-patient HOCl bag's way. Bad news arrives as verified.

Depends on it: Legal & IP (C19, bound); Technology & R&D

If it is false: If false, one P1 per-patient HOCl bag session costs more than the per-session price. A session is a head assembly with its chamber and valves, plus a bag divided by the sessions it really serves. The test fails at the business case's volume, at a tenth of it, or in the setting where a bag serves the fewest sessions. Then P1 per-patient HOCl bag loses money per irrigation somewhere it is meant to sell. Where a bag serves one session, P1 per-patient HOCl bag costs more than P0 the original shape did, because the head now has a pump in it. Successor to A53 At the annual kit volume the business case… (claim 129unconfirmed). It cannot be attempted until a price and a bill of materials exist, so it is expected back unconfirmed.

Depends on it: Operations & NPI (C6, bound; rebinds superseded claim 129unconfirmed); Commercial (REQ-0244 For P1: the price and the volumes); Technology & R&D (the bill of materials)

If it is false: If false, in at least one of the four settings the in-use period the data support is shorter than the usual gap between sessions, or the opened bag needs refrigeration. In that setting one bag serves one session, so a session costs a head plus a full bag (A114). A refrigerated opened bag also breaks home health, where storage is uncontrolled. Twins: A89 In US outpatient wound clinics the interval… (claim 163unconfirmed), and P1 per-patient HOCl bag-a (A93 The system's hypochlorous acid-preserved…, A103), which supplies the period this row compares.

Depends on it: Operations & NPI (C8, bound); Commercial (its C4, A89 In US outpatient wound clinics the interval…, is the outpatient half); Clinical & Scientific (REQ-0245 For each intended-use setting, the session intervals)

If it is false: A threat row. If false, the registry read missed contract fillers of sterile HOCl in bags, and the supply concern shrinks. The row is here for the other direction. If true, the only contract maker listing an HOCl wound solution makes it for Urgo, and no contract maker lists sterile HOCl in a flexible bag. Then A52 Sterile HOCl wound-irrigation solution… (claim 128unconfirmed, two independent fillers) has nothing under it in the public record. P1 per-patient HOCl bag's bag is then sourced from an incumbent or made in-house, now with a custom keyed port (A88 US facility and agency purchasers). Bad news arrives as verified.

Depends on it: Operations & NPI (C9, bound: its answer to REQ-0229 From public records first); Commercial (the shape-(c) supply route); Legal & IP (supply from a licensed incumbent turns FTO into a contract term)

If it is false: If false, under worst-case use a direct-reading monitor in the operator's breathing zone reads chlorine above the 1 ppm Table Z-1 ceiling, or droplet concentration is higher with the shield fitted than without it. Then the working-environment proposition reverses. The shield gathers an above-limit exposure at face height, the system needs respiratory controls, and shield and nozzle tooling waits on a redesign. Twins: A72 During simulated wound irrigation with the… (claim 148unconfirmed), A99 In simulated or clinical use (claim 173unconfirmed, a stricter pass mark) and A34 Open safety question (claim 51unconfirmed). Needs a built head, so expected back unconfirmed.

Depends on it: Operations & NPI (C10, bound; it owns the pass mark under REQ-0227 Own the staff-exposure pass mark for HOCl…); Technology & R&D (A72 During simulated wound irrigation with the…); Clinical & Scientific (A99 In simulated or clinical use); Commercial

If it is false: If false, after production sterilization and ageing, the chamber and check valves crack, leak, fail or shed particulate within twice a full session's squeeze cycles. Then the head fails in use the way the Surgiphor squeeze containers did, the valved assembly is redesigned and re-verified, and delivered pressure (A69 The kit's three-nozzle head) cannot be relied on late in a session.

Depends on it: Operations & NPI (C11, bound); Technology & R&D

If it is false: If false, an in-force US patent or pending application outside the named families claims a single-use head with a hand-squeezed chamber refilled through a check valve, or a head-to-bag connector keyed to one maker's bag. Then FTO for the two elements P1 per-patient HOCl bag added is blocked by an unnamed holder until a licence or a design-around exists, and the keyed connector that P1 per-patient HOCl bag-b rests on may be someone else's. Extends A79 Apart from the patent families named in… (claim 155unconfirmed) to P1 per-patient HOCl bag's new elements. A sweep cannot verify an absence, so it is expected back unconfirmed.

Depends on it: Legal & IP (C20, bound); Technology & R&D; Commercial

If it is false: Both directions break something. If false, the first US sale of the P1 per-patient HOCl bag head comes after 2032-03-14. That is more than five years out, and the calendar to first revenue runs past early 2032. If true, the head launches inside a live Schultz term (about 2032-04 on A76 US 8,672,904 B1, later on A108 or A109). Counsel's read of A107's claims against the defined head, or a design-around, then becomes a launch item rather than a wait. Operations' own declared estimate, which is not a claim, is late 2028 to late 2030. It needs a supplier and a confirmed route, so it is expected back unconfirmed.

Depends on it: Operations & NPI (C12, bound: its answer to REQ-0250 What is the earliest plausible date the P1…); Legal & IP (its blocks trigger turns on the launch date); Regulatory (the head's route, A106)

If it is false: If false, no single connector on the per-patient bag both accepts only this maker's head and reseals between sessions, or FDA would not accept a maker-keyed port on a wound-irrigation bag inside a 510(k) or exempt route. Then the head cannot be made to fit only this bag. It is sold for any bag, which is neighbour (a), and the bag has to win alone as a parity HOCl solution. That is the same consequence as P1 per-patient HOCl bag-b (A88 US facility and agency purchasers) failing, reached from the engineering and clearance side rather than from the buyer's. If keying survives and resealing does not, A94 The per-patient bag's access port accepts a… (claim 168unconfirmed) fails with it and so does the opened bag (A93 The system's hypochlorous acid-preserved…, A103). Under the spent pivot budget, a failure here is recorded as commission, and the next shape is the owner's decision. Twins: A88 US facility and agency purchasers (claim 162unconfirmed, buyers accept the keyed head) and A94 The per-patient bag's access port accepts a… (claim 168unconfirmed, the port recloses).

Depends on it: Front end, through /assess (pillar B2 The single-use head is keyed to this…: P1 per-patient HOCl bag-c, the unstated premise named at loop turn 2); Technology & R&D (REQ-0234 In the P1 reference design: whether keying and resealing can share one connector); Regulatory (REQ-0255 P1's mechanism makes the single-use head…: whether FDA accepts a non-standard, maker-keyed port); Commercial (the head's fit is P1 per-patient HOCl bag's pull-through, A88 US facility and agency purchasers); Operations & NPI (a keyed port makes the bag a custom part, A52 Sterile HOCl wound-irrigation solution…, A116); Legal & IP (the keyed connector is unsearched, A119)