Evidence · idea-023

FDA 510(k) K123072 (an FDA 510(k) clearance number), Vashe Wound Therapy Solution (Puricore, Inc.), product code FRO, was cleared on 2013-02-14. Its summary describes an aqueous wound cleanser containing hypochlorous acid as a preservative (available free chlorine 150-330 ppm, pH 3.5-6.75). Its indications cover cleansing, irrigating, moistening and debriding acute and chronic dermal lesions, including Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, and first- and second-degree burns.

FDA 510(k) K131848 is a further clearance for Vashe Wound Solution in 4.0, 8.5 and 16.0 oz sizes. The Generator believes it is product code FRO with the same HOCl-as-preservative framing, and has not read its summary.

FDA 510(k) K232080, Puracyn Plus Antimicrobial Irrigation Solution (Innovacyn, Inc.), was cleared on 2024-05-31 as a traditional 510(k). It is described as a sterile wound irrigation solution containing hypochlorous acid as an antimicrobial preservative, applied with irrigation to cleanse and remove debris from wounds by mechanical action. It is supplied in 1000 mL and 3000 mL flexible bags for prescription use. The Generator believes its product code is FRO and has not confirmed it.

FDA 510(k) K142592, CleanSmart Wound Cleanser (Simple Science, LLC), was cleared on 2015-09-02. It is described as containing hypochlorous acid 0.011% and hypochlorite ion 0.002%, with a mechanical mechanism of action (flow across the wound removes debris). It carries OTC indications for minor wounds and Rx indications for Stage I-IV pressure ulcers, diabetic foot and leg ulcers, post-surgical wounds and burns. The summary reports bench testing only, including preservative effectiveness and 12-month stability.

FDA 510(k) K243415, Granudacyn Wound Irrigation Solution (applicant P.G.F. Industry Solutions GmbH; correspondent Mölnlycke Health Care US, LLC), product code FRO, was received on 2024-11-01 and found substantially equivalent on 2025-07-22.

FDA product code FRO is named "Dressing, Wound, Drug". It is an unclassified, pre-amendment device type, cleared through 510(k) with no classification regulation.

Federal Register document 2023-26209 (published 2023-11-30, Docket FDA-2023-N-3392) is an FDA proposed rule to classify certain solid wound dressings, wound dressings formulated as a gel, cream or ointment, and liquid wound washes that contain antimicrobials and/or other chemicals. It proposes Class III (FDA device class III) for antimicrobials of high antimicrobial-resistance concern and Class II (FDA device class II) with special controls for medium or low concern. It proposes new sections 21 CFR 878.4016, 878.4017 and 878.4019, the last covering liquid wound washes. It names current product codes FRO, GER, MGP, MGQ and EFQ.

Generator's belief: as of 2026-10-04, proposed rule 2023-26209 has not been finalized, so liquid wound washes containing HOCl remain clearable by 510(k) as unclassified FRO devices. If it has been finalized, the tier FDA assigned to HOCl decides whether the launch route is a Class II 510(k) with special controls or a Class III PMA.

FDA 510(k) K080779, IRRISEPT Wound Debridement and Cleansing System (IRRIMAX Corporation), was prepared in August 2008. It is described as a manual, self-contained irrigation device containing 0.05% chlorhexidine gluconate solution, classified as jet lavage under 21 CFR 880.5475, product code FQH, Class II.

FDA 510(k) K240552, Irrisept Antimicrobial Wound Lavage, was cleared on 2024-06-18 under product code FRO. It is a single-use, self-contained irrigation system (450 mL bottle of 0.05% CHG in sterile water) in which CHG acts as a preservative. Its intended use is mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds.

21 CFR 880.5475 defines a jet lavage as a device used to clean a wound by a pulsatile jet of sterile fluid. It consists of the pulsing head, tubing to a container of sterile fluid, and a means of propelling the fluid, such as an electric roller pump. It is Class II (special controls) and exempt from premarket notification subject to 21 CFR 880.9.

FDA 510(k) K210987, IRRIGO Wound Wash Jet System, product code FQH, was cleared on 2022-05-31. It is a sterile, single-patient-use jet lavage device that a clinician squeezes by hand to generate a pulsatile saline stream of up to 15 psi. It is indicated for cleansing and moistening traumatic wounds such as pressure sores, diabetic and vascular leg ulcers, cuts, abrasions and minor burns.

21 CFR 880.6960 classifies an irrigating syringe: a bulb or piston syringe, with an integral or detachable tube, used to irrigate, withdraw fluid from, or instill fluid into a body cavity or wound. It is Class I, exempt from premarket notification subject to 21 CFR 880.9, under product code KYZ ("Syringe, Irrigating (Non Dental)").

FDA 510(k) K974288, Zerowet Splashield (Zerowet, Inc.), product code KYZ under 21 CFR 880.6960, was received on 1997-11-14 and found substantially equivalent on 1998-01-29. It is a cleared precedent for a wound-irrigation splash shield accessory.

HCPCS (Healthcare Common Procedure Coding System) Level II code A6260 (a HCPCS code for a supply) exists with the descriptor "Wound cleansers, any type, any size".

Under the DME MAC (durable medical equipment Medicare administrative contractor) surgical dressings policy, wound cleansers (A6260) and irrigating solutions are non-covered under the Medicare Part B (Medicare Part B) surgical dressing benefit because they are not dressings. A Noridian DME (durable medical equipment) article titled "Non-Covered Surgical Dressings" says so. The Generator believes the controlling documents are LCD (local coverage determination) L33831 (a Medicare local coverage determination number) and policy article A54563 and has not confirmed those numbers.

TAM (total addressable market) denominator: Carter MJ et al., "Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019", J Med Econ 2023;26(1):894-901 (PMID (PubMed identifier) 37415496), reports that Medicare beneficiaries with a wound increased from 8.2 million to 10.5 million, a prevalence of 14.5% rising to 16.4%. The count spans all wound types in the study's definition, not only the indications in this candidate.

Nussbaum SR et al., "An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds", Value Health 2018;21(1):27-32 (the Generator believes PMID 29304937), reports about 8.2 million Medicare beneficiaries with wounds and total Medicare wound spending estimates of $28.1-96.8 billion.

Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ, "Water for wound cleansing", Cochrane Database Syst Rev 2022, Issue 9, CD003861.pub4 (PMID 36103365), included 13 trials with 2504 participants. It compared tap, distilled or boiled water with no cleansing or with other solutions such as saline. The Generator recalls its conclusion as low- to very-low-certainty evidence with no clear difference in infection or healing between tap water and saline.

The OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030, requires appropriate personal protective equipment, including eye and face protection, wherever splashes, spray, spatter or droplets of blood or other potentially infectious materials can reasonably be anticipated. The Generator reads wound irrigation as such a task.

FTO (freedom to operate), solution: US 8,871,278, "Stabilized hypohalous acid solutions", lists Puricore, Inc. as assignee. Web sources report it filed 2012-03-19, which gives a naive expiry around 2032, and later assigned through Realm Therapeutics to Urgo US, Inc. Family members surfaced by search include US 9,392,787, 9,414,584, 10,034,942, 10,576,152 and 11,452,778. The Generator has not read the claims, priority dates, term adjustments or legal status, and does not know whether any claim reads on an HOCl irrigation solution of the kind this kit would use.

FTO, device: US 6,050,981, "Wound irrigation system with flexible shield" (inventors Lampropoulos et al.; assignee Merit Medical Systems, Inc.), claims a flexible, conformable irrigation shield disposed on a fluid delivery device. The Generator believes it was granted in 2000 and is expired. Grant date and status are not confirmed.

FTO, device: US 8,002,757, "Splash shield systems" (inventor Joseph P. Schultz; reported assignee Splash Medical Devices LLC), covers splash shields for wide-mouth irrigation squeeze bottles and other irrigation fluid sources. It was filed 2007-05-24 and granted 2011-08-23, giving a naive expiry around 2027 before any term adjustment. Related Schultz patents surfaced by search, which may extend live coverage into the 2030s, are US 8,672,904 ("Splash shield systems"), US 8,747,372, US 10,576,198 and US 12,208,226 ("Abscess irrigation systems"). Their claims, continuity and status were not read.

Other wound-irrigation splash-shield patents surfaced by title only, with status not checked and most believed expired: US 4,769,003; US 5,496,290; US 6,093,182; US 6,402,724; US 7,540,860; US D345,016.

Restates the OPPS part of claim 30unconfirmed on its own: 42 CFR 419.2(b)(4) lists 'medical and surgical supplies and equipment; surgical dressings' among the costs packaged into the hospital outpatient prospective payment for the related procedure or service.

42 CFR 413.335(b)(1) states that the SNF prospective per diem rates represent payment in full for all costs (routine, ancillary, and capital-related) associated with furnishing inpatient SNF services, and 42 CFR 411.15(p) excludes from coverage services furnished to an SNF resident during a covered Part A stay by an entity other than the SNF absent an arrangement.

42 CFR 484.205(d) states that the national, standardized home health prospective payment amount represents payment in full for all costs associated with furnishing home health services, and 42 CFR 409.100(a)(2) directs payment for home health services, including medical supplies, to the HHA.

TAM volume floor, not a count of irrigations: the CMS Medicare Physician and Other Practitioners by Geography and Service file for data year 2024 records, at national level, 684,939 services under CPT 97597, 2,042,234 under 11042, 506,331 under 11043 and 650,800 under 11045 (Medicare fee-for-service Part B practitioner claims only).

Price anchor for the saline comparator: HCPCS A4217 (sterile water/saline, 500 ml) has a July 2026 Medicare DMEPOS fee schedule amount of $3.80 to $4.47 (non-rural, 49 contiguous states/DC), and A4322 (irrigation syringe, bulb or piston) $3.78 to $4.35. These are Medicare allowed amounts, not market prices.

FDA 510(k) summary K210987 describes its predicate Saline Wound Wash as delivering 'published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15 AHCPR, US Health and Human Services)', and states the IRRIGO bottle 'can generate upto 15 psi of stream pressure'.

FDA cleared K253665, Vashe Plus Antimicrobial Solution (Urgo Medical North America), on 2026-08-11 under product code FRO, with an IFU for cleansing, irrigating, debridement (slough removal), moistening and removal of foreign material including microorganisms and debris from acute and chronic dermal lesions including Stage I-IV pressure ulcers, stasis ulcers and diabetic ulcers, under healthcare-professional supervision.

Competitive entry: in addition to K243415 and K251757, FDA cleared further professional-use wound cleanser solutions under product code FRO in 2025-2026, including K243875 Spectricept Skin and Wound Cleanser (2025-04-21), K252023 MiraChlor Wound Cleanser Solutions (2026-03-25) and K253665 Vashe Plus Antimicrobial Solution (2026-08-11).

Restates claim 55refuted with the inventor of record: US 5,941,859, 'Wound irrigation shield with fluid scavenging', names Benjamin S. Lerman as inventor and applicant, was filed 1997-03-17 and published 1999-08-24, and is recorded in INPADOC as lapsed for failure to pay the maintenance fee (effective 2003-08-24).

FTO field lead (warmed irrigation): US 12,178,977 B2 The single-use head is keyed to this…, 'Lavage systems and devices having warming component' (applicant CareFusion 2200, Inc.), filed 2021-10-14, is recorded in INPADOC as in force with a naive term to 2041-10-14; a continuation, US 2025/0082838 A1 Assumption, is pending. Its claims have not been read against the kit.

FTO field lead (irrigation containment): US 10,391,207 B2 The single-use head is keyed to this…, 'Irrigation fluid containment systems', filed 2017-07-20, is recorded in INPADOC as in force with a naive term to 2037-07-20, in the family of US 2016/0095964 A1 Assumption (Dilip Tapadiya M.D., Inc.). Its claims have not been read against the kit.

FTO field lead closed: US 2020/0069862 A1 Assumption, 'Splashback shield for wound cleansing', filed 2018-09-03, is recorded in INPADOC as abandoned on 2024-09-09 for failure to respond to an office action, with no other US family member.

FTO field lead closed: the US members of PuriCore's WO 2008/040020 A2 FDA 510 family named in claim 58unconfirmed's note, US 2010/0030132 A1 Assumption and US 2013/0261534 A1 Assumption, are both recorded in INPADOC as abandoned (2013-07-24 and 2017-01-22) for failure to respond to an office action.

Bears on claim 53unconfirmed: in the Oculus Innovative Sciences 'oxidative reductive potential water solution' family, US 9,168,318 B2 The single-use head is keyed to this… (filed 2004-08-11), US 9,642,876 B2 The single-use head is keyed to this… and US 10,016,455 B2 The single-use head is keyed to this… are recorded in INPADOC as lapsed for unpaid maintenance fees (effective 2019-10-27, 2025-05-09 and 2026-07-10 respectively).

Bears on claim 53unconfirmed, against its 'expired' framing: related Oculus/Sonoma method-of-use patents on oxidative reductive potential water remain recorded as in force: US 8,834,445 B2 The single-use head is keyed to this… (peritonitis, naive term to 2032-03-30), US 9,072,726 B2 The single-use head is keyed to this… and US 9,782,434 B2 The single-use head is keyed to this… (inflammation and hypersensitivity, naive terms to 2029-12-21 and 2035-07-07), and Sonoma's US 10,342,825 B2 The single-use head is keyed to this…, 'Solution containing hypochlorous acid and methods of using same' (naive term to 2030-06-15; INPADOC record last exchanged 2023-01-07). None has been read against wound irrigation.

Bears on claim 40unconfirmed with a retrievable source: the International Wound Infection Institute's 2022 consensus 'Wound Infection in Clinical Practice' (Wounds International) states that passive soaking or swabbing may not adequately cleanse the wound and that 'Mechanical irrigation applied at a force of 4–15 pounds per square inch (PSI) is recommended', with a table giving 8 psi for a 35 mL syringe with a 19G needle/angiocatheter and 4 psi with a 25G.

The same IWII 2022 consensus states that hydrogen peroxide, traditional sodium hypochlorite (EUSOL, Dakin's solution) and chlorhexidine are no longer recommended for use in open wounds because of the risk of tissue damage.

Bears on claim 41unconfirmed: in an experimental wound study, saline irrigation delivered at 15 psi removed 84.8% of soil infection-potentiating factors from the wound (Rodeheaver et al., Surg Gynecol Obstet 1975).

Bears on claim 41unconfirmed: in experimental wounds, low-pressure irrigation with an asepto syringe did not significantly cleanse the wound of bacterial contaminants, while high-pressure syringe irrigation removed bacteria and lowered the infection rate (Stevenson et al., JACEP 1976).

Bears on claim 41unconfirmed: in standardized surgical wounds in pigs, high-pressure syringe and pulsatile irrigation disseminated fluid laterally into adjacent tissue and caused a tissue injury that impaired its defenses (Wheeler et al., Surg Gynecol Obstet 1976).

Against a steep pressure threshold: in Staphylococcus aureus-inoculated rat wounds, lower-pressure higher-volume irrigation (mean 1.6 psi) and syringe-catheter irrigation (mean 8.8 psi) were equally effective at washing out bacteria at all times studied.

Against a pressure benefit in its setting: the FLOW trial (41 centres, 2,447 analysed patients with open extremity fractures) found 12-month reoperation of 13.2% with high (>20 psi), 12.7% with low (5-10 psi) and 13.7% with very low (1-2 psi) irrigation pressure, with no significant pairwise difference; castile soap had more reoperations than saline (14.8% vs 11.6%, HR 1.32).

Restates claim 45unconfirmed: the Barrigah-Benissan 2022 systematic review of antiseptics for chronic wounds included 6 RCTs with 725 patients (1989-2020) and states 'No studies assessing chlorous agents met our eligibility criteria' and 'We could not assess the effect of hypochlorous agents on chronic wound healing'.

Restates claim 47unconfirmed without the two unsupported details: Maragakis et al. (JAMA 2004) investigated multidrug-resistant Acinetobacter baumannii in 11 patients at a 1000-bed tertiary care hospital in Baltimore in 2003; 6 of 7 cases versus 4 of 28 controls had pulsatile lavage (OR 36, 95% CI 2.8-1721), and one strain was recovered from all 6 typed lavage patients and from multiple surfaces in the wound care area.

Cochrane review 'Wound cleansing for treating venous leg ulcers' (2021) included 4 RCTs with 254 participants and found insufficient, very-low-certainty evidence for PHMB versus saline, propyl betaine/polihexanide versus saline, aqueous oxygen peroxide versus water and octenidine versus Ringer's; no trial compared cleansing with no cleansing or compared techniques.

Bears on claim 50unconfirmed: a 200 ppm, pH 6 hypochlorous acid solution was unstable against UV light, sunshine, contact with air and elevated temperature (25 C or higher), and the authors recommend storage in dark, cool conditions below 10 C to maintain HOCl concentration (Biocontrol Sci 2017).

Bears on claim 50unconfirmed: neutral electrolysed water (480 mg/L available chlorine) stored at 25 C fell to below 0.01 mg/L available chlorine after 52 days in bottles with a surface-area-to-volume ratio of 8.7, and was significantly more stable at 4 C (J Food Prot 2020).

Bears on claim 50unconfirmed, from a different chemistry: 1%, 2.62% and 5.25% sodium hypochlorite endodontic irrigants held at 20, 45 and 60 C for 60 minutes 'remained stable' by iodometric titration (J Endod 2005). These solutions are alkaline and far more concentrated than HOCl wound cleansers.

Bears on claim 51unconfirmed: cultured human skin fibroblasts exposed to aerosolized HOCl dry fog from a 500 ppm solution for 9 minutes showed significant cytotoxicity and genotoxicity, while exposure to fog from a 300 ppm solution for 3 minutes, once or four times, showed no analogous damage (PLoS One 2024).

Bears on claim 51unconfirmed by analogy only (surface disinfection, not wound irrigation): in a controlled study of sodium hypochlorite applied by spraying versus wiping, chlorine gas concentrations remained below detection limits, and spraying gave a lower cumulative inhaled ultrafine-particle dose than wiping because it was faster (J Occup Environ Hyg 2026).

Bears on claim 49unconfirmed (a quantitative splash study does exist, at syringe pressure): in a beef wound model irrigated with 200 mL by 50 mL syringe, ten runs per device, an Irrijet system with a 12.7 cm splash shield and a Zerowet Splashield produced significantly less splatter on the irrigator's face and chest than an 18-gauge angiocatheter, and no facial splatter occurred with the Zerowet held against the wound (Ann Emerg Med 1993).

In a rat blast-amputation model, all animals irrigated with 20 psi pulsatile lavage developed soft-tissue radiopaque lesions (myonecrosis and dystrophic calcification) and none irrigated by bulb syringe did (p=0.001); wound complications occurred in 5 of 12 lavage animals versus none in the other groups.

Revealed-behaviour twin for claim 62unconfirmed (contracting, not price): Urgo Medical North America announced on 2020-02-28 a Premier group purchasing agreement for Primary, Secondary Wound Care Dressings and Wound Debridement, effective 2020-04-01, giving Premier members pre-negotiated pricing for Vashe, Drawtex and UrgoTul. The contract price is not disclosed.

Revealed-behaviour twin for claim 62unconfirmed (federal contracting, not price): Urgo Medical North America announced on 2019-01-30 a Federal Supply Schedule contract for the Vashe line, available under FSS #V797D-50441 and DAPA #SP0200-05-H-0090. The contract price was not retrieved.

Price observation for claim 37unconfirmed, retail not contract: on 2026-10-04 an online retailer listed Vashe Wound Cleanser 34 oz (1 L) flip-top bottle at $849.98 per case of 6 (about $141.66 per bottle), and Puracyn Plus 32 oz instill/spikeable bottle at $440.98 per case of 6 (list).

Market-size sanity check from one HOCl incumbent: Sonoma Pharmaceuticals' Form 10-K for the fiscal year ended 2025-03-31 reports total revenue of $14.288 million, of which United States revenue was $2.611 million (down 15% from $3.058 million) and Europe $5.523 million; US revenue covers all of its products, not only wound care.

Revealed-behaviour twin for 'clinicians believe HOCl beats saline' (utilization, one site): in a retrospective cohort of 274 grafted burn patients at one ABA-verified US burn centre (2012-2024), 88.7% received mafenide acetate and 11.3% hypochlorous acid as the initial antiseptic, and infection requiring antibiotics did not differ (41.9% HOCl vs 37.0% mafenide, P=.58).

Practice survey (Canada, June-August 2024, nurses): 68% (n=135) supported gauze soaking but 30% (n=59) used it routinely, and 34% (n=67) considered hypochlorous acid and sodium hypochlorite equally safe. It reports no share of cleansings done by pressurized irrigation.

Pulsed saline lavage price point from one institution: a break-even analysis used an institutional protocol cost of $38.28 for pulsed saline lavage in primary total knee and hip arthroplasty (Arthroplasty Today 2022).

Mölnlycke Health Care announced on 2025-05-27 that it had completed the acquisition of P.G.F. Industry Solutions GmbH (Elixhausen, Austria), the manufacturer of Granudacyn, which Mölnlycke distributes in over 50 countries.

Proposed rule FR Doc 2023-26209 (88 FR 83774, published 2023-11-30) would limit antimicrobial preservatives in liquid wound washes to non-sterile or multiple-use single-patient products. Proposed 21 CFR 878.4019(a)(1) reads 'Antimicrobials are used for preservative purposes only to maintain shelf life for a nonsterile liquid wound wash or a multiple-use liquid wound wash for single patient use only'. The preamble states 'An antimicrobial preservative use is not appropriate for a sterile, single-use product' and lists 'Antimicrobial preservative claims for a sterile, single-use product' among the labeling claims it proposes as not appropriate.

Table 2 of proposed rule FR Doc 2023-26209 lists hypochlorous acid in the column 'Antimicrobials with low-level AMR concern'. Proposed 21 CFR 878.4019(b)(2) would classify as Class II (special controls) the liquid wound washes within 878.4019(a) that contain antimicrobials acting as preservatives with a medium or low level of AMR concern. Class III (PMA) under proposed 878.4019(b)(1) is reserved for medically important antimicrobials.

Proposed rule FR Doc 2023-26209 states that a labeling use to 'Deliver antimicrobials to the wound' suggests an intent for the treatment or prevention of infection that generally would be achieved through chemical action within or on the wound and 'may not fall under CDRH (Center for Devices and Radiological Health)'s jurisdiction'. It also states that a use for 'Treatment of or cure for wounds' falls within product codes MGR or MDD, which are regulated as postamendments class III devices subject to PMA.

The FDA 510(k) summary for K232080 (Puracyn Plus Antimicrobial Irrigation Solution, hypochlorous acid as an antimicrobial preservative, supplied sterile in 1000 mL and 3000 mL flexible bags) gives the subject device's use as 'Multiple use within a single patient' in its comparison table.

The FDA 510(k) summary for K240552 (Irrisept Antimicrobial Wound Lavage, FRO, 2024-06-18) describes the co-packaged accessories as sterile pouched accessories (spikeable cap and hangers) that facilitate fluid delivery. It does not describe a spray head, nozzle or splash guard as part of the cleared device.

FDA 510(k) summary K240552 (Irrisept Antimicrobial Wound Lavage, Wound Solution Kit, product code FRO) describes a 450 mL Blow-Fill-Seal bottle of aseptically processed 0.05% CHG solution (aseptic processing per ISO 13408, leveraged from K210536), supplied in a shelf box with separately pouched accessories (spikeable cap and hangers) that are sterilized by ethylene oxide per ISO 11135, with the bottle exterior non-sterile. The one cleared self-contained antiseptic irrigation kit in this file is therefore manufactured as two separately sterilized sub-assemblies joined at the point of use, not as one pre-connected system sterilized as a whole.

FDA 510(k) summary K232080 (Puracyn Plus Antimicrobial Irrigation Solution) states that the solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bags, each packaged in a sealed foil pouch, and lists as performance testing: stability per ICH Q1A(R2), biocompatibility per ISO 10993-1, packaging per ISO 11607-1 and -2, sterilization per ISO 11737-1 and -2, endotoxin per USP <85>, preservative effectiveness per USP <51>, sterility per USP <71> and bioburden per USP <61> and <62>. The summary does not state whether the bags are aseptically filled or terminally sterilized, or by which method.

ClinicalTrials.gov record NCT07440797, sponsored by Laboratoires URGO, registers a randomized, open-label trial of Vashe solution versus saline solution in venous or mixed leg ulcers with inflammatory signs (estimated enrollment 102, primary outcome clinical success at week 4), which as of 2026-10-04 is not yet recruiting and has no results posted.

Published bench measurement (Ann Emerg Med 1994, PMID 8010547; ten volunteers irrigating 250 mL boluses of normal saline): a hand-compressed IV bag pierced with a 19-gauge needle produced a median peak irrigation pressure of 4 psi (range 2 to 5.5 psi), and an IV bag with tubing inside a pressure cuff inflated to 400 mmHg (millimetres of mercury) produced 6 to 10 psi through a 19-gauge needle and 4 to 6 psi through a 16-gauge needle.

FDA has cleared antiseptic wound-irrigation systems supplied as a solution container plus applicator in one package and joined by the user at the point of use rather than pre-connected: the K080779 (IRRISEPT) 510(k) summary describes a prepackaged box containing one bottle and one splashguard that is removed from its pouch and screwed onto the bottle, and the K253445 (BD Surgiphor 1000 mL Antimicrobial Irrigation System, product code FQH) summary describes a terminally sterilized 1000 mL solution bottle supplied in a tray with a screw cap with spike for manual squeeze irrigation and an adaptor for a powered lavage device.

Independent claim 1unconfirmed of US 8,871,278 B2 The single-use head is keyed to this… ('Stabilized hypohalous acid solutions', Urgo US / PuriCore family, priority 2011-03-18) is limited to a hypochlorous acid solution or hydrogel prepared by electrolysis of an NaCl solution that contains a stabilizing amount of dissolved inorganic carbon added as a bicarbonate or carbonate (300-1500 mg/L, DIC:AFC ratio not more than 5:1), at 100-500 ppm available free chlorine, pH 5-7 and salinity about 0.02-1.0%, in a container nonpermeable by CO2 or O2.

Independent claim 1unconfirmed of US 10,342,825 B2 The single-use head is keyed to this… ('Solution containing hypochlorous acid and methods of using same', Sonoma Pharmaceuticals) is limited to a low-pH antimicrobial solution with a pH of 5.6, a free available chlorine concentration of 60-150 mg/L, a chloride ion concentration of 4-75 mg/L, and a sodium phosphate monobasic plus dibasic buffering agent.

US 8,002,757 B1 US hospitals ('Splash shield systems', inventor Joseph P. Schultz) is no longer in force as of 2026-10-04: its statutory term, counted from the earliest US non-provisional application to which it claims benefit, has ended.

US 8,672,904 B1 US hospitals, US 11,083,835 B2 The single-use head is keyed to this… and US 12,208,226 B2 The single-use head is keyed to this… (Schultz splash-shield / abscess-irrigation family) each claim US benefit from an application filed in 2009 or 2010, and none has a statutory term (including patent term adjustment) running past 2032-12-31, notwithstanding the INPADOC naive terms of 2030, 2039 and 2041.

Every independent claim of US 12,178,977 B2 The single-use head is keyed to this… (CareFusion 2200, 'Lavage systems and devices having warming component') recites a warming component that transfers energy to the lavage fluid.

US 12,642,907 B2 The single-use head is keyed to this…, 'Manual and battery powered wound washing gun' (filed 2024-01-19, published as US 2025/0235602 A1 Assumption), is recorded in INPADOC as in force with a naive term to 2044-01-19, and US 10,568,785 B2 The single-use head is keyed to this… (Medaxis AG family of US 2017/0049641 A1 Assumption, 'Protective cover') is recorded in INPADOC as in force with a naive term to 2036-08-12; the claims of neither have been read against the kit.

WO 2008/040020 A2 FDA 510 (PuriCore Inc., 'Apparatus and method for wound, cavity, and bone treatment', published 2008-04-03), classified in CPC A61M3, discloses an apparatus for delivering a hypochlorous acid solution to a wound.

42 CFR 414.22(b)(5) states that, for services furnished in 2002 and later, practice expense RVUs are based entirely on relative practice expense resources, and 414.22(b)(5)(i) applies facility practice expense RVUs to services furnished to patients in a hospital or a skilled nursing facility and nonfacility practice expense RVUs to services furnished in all other locations, including a physician's office and the patient's home.

The FDA 510(k) summary for K251757 (Puracyn Plus Antimicrobial Irrigation Solution, Innovacyn, Inc., decided 2026-01-05, predicate K232080) states that the solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bags, each in a sealed foil pouch, manufactured using aseptic techniques, labelled for multiple use within a single patient, with composition purified water, hypochlorous acid and sodium phosphates, and that design compatibility testing showed it compatible with the InterPulse, Pulsavac and MicroAire jet lavage systems; the summary states no in-use period after first opening.

Randomized trials of warmed versus room-temperature saline wound irrigation report patient-comfort benefits and, where wound outcomes were measured, no difference in them: in a single-blind crossover RCT of 38 emergency-department patients with simple linear lacerations (South Med J 2003, PMID 12911180), significantly more patients preferred warmed saline (difference 34%, 95% CI 5.7-63) with no difference in VAS pain (P=0.082); and in a parallel RCT of 149 digit-replantation patients (Adv Wound Care 2026, PMID 42392970), warmed saline at dressing changes reduced pain and anxiety (p<0.001) with no between-group difference in complication rates, C-reactive protein or digit survival.

Proposed 21 CFR 878.4019(b)(2) in FR Doc 2023-26209 would make the special controls for a Class II liquid wound wash require that, if the product is intended for multiple uses after opening, continued low bioburden, product stability and functionality over the identified use life be demonstrated; that the period of preservative effectiveness after opening be identified from the antimicrobial's concentration and from preservative effectiveness testing under worst-case simulated use conditions; and that preservative effectiveness testing be run on at least three manufactured lots real-time aged for the stated shelf life, with multiple-use test articles also conditioned by worst-case simulated use for maximum use life.

The FDA 510(k) summary for K253665 (Vashe Plus Antimicrobial Solution, product code FRO, cleared 2026-08-11) reports USP <51> preservative effectiveness testing on 9-month aged samples that included a simulated 7-day multi-use period with repeated dispensing, material compatibility testing of the solution with vented spike adapter materials (PVC and medical-grade silicone), and a GLP porcine wound healing study, and states 'No clinical data was required to support substantial equivalence'.

The FDA 510(k) summary for K210987 (IRRIGO Wound Wash Jet System, a hand-squeezed jet lavage device under product code FQH) supports substantial equivalence with bench testing (including 'IRRIGO PSI Testing/Internal Pressure Curves'), sterilization and biocompatibility testing, and reports no clinical testing.

The independent claims of US 11,083,835 B2 The single-use head is keyed to this… are claims 1 and 8 (of 20), and those of US 12,208,226 B2 The single-use head is keyed to this… are claims 1, 10 and 20 (of 20); none of these five recites a squeeze bottle or a syringe as the fluid source, each instead reciting a 'fluid source connector' or 'irrigation source connector' together with 'a fluid delivery nozzle' and a shield; '835 claim 8verified and '226 claim 10unconfirmed each require a shield forming an inner hollow with a circumferential wall that completely encircles the nozzle (in '226 claim 10unconfirmed, at least a proximal portion of it) along its longitudinal axis, with the nozzle's distal tip distal to the wall's distal end; '835 claim 1unconfirmed requires an adjustable shield connector plus both an extended shield and an abbreviated shield, each configured to be removably attached to it; '226 claim 1unconfirmed requires a shield connector, a nozzle extending beyond it, and an extended shield configured to be removably attached to it so that the nozzle tip does not extend beyond the extended shield's distal end; and '226 claim 20unconfirmed is a method using an irrigation device capable of an abscess irrigation configuration and a wound irrigation configuration, with a removable shield. (Text as printed in the USPTO grant images; this is what the claims recite, not a reading of them against any device.)

US 10,363,356 B2 The single-use head is keyed to this… (Schultz, 'Abscess irrigation systems', application 14/296,651 filed 2014-06-05) prints on its grant face a benefit claim as a continuation of application 12/851,476 (filed 2010-08-05), which the same face describes as a continuation-in-part of applications reaching back to 09/484,666 filed 2000-01-18, and a patent term adjustment of 1,014 days; counted under 35 U.S.C. 154(a)(2) from 2000-01-18, its statutory term ended about 2022-10-28, before 2026-10-04, notwithstanding the INPADOC naive term to 2034-06-05.

US design patents D956,963 S (application filed 2018-11-16) and D1,085,409 S (application filed 2022-05-25), each titled 'Abscess irrigation device' and in the INPADOC family of the Schultz splash-shield patents, each have a term of 15 years from their own grant date under 35 U.S.C. 173, so their terms are not counted from the family's 2009-2010 utility filings and are not bounded by the about-2032 end of US 8,672,904, US 11,083,835 and US 12,208,226.

US 12,642,907 B2 The single-use head is keyed to this… ('Manual and battery powered wound washing gun', granted 2026-06-02, 6 claims) has claim 1unconfirmed as its only independent claim, and claim 1unconfirmed recites a battery housed within the housing and a pump operatively connected to the battery, together with a reservoir housed within a barrel section and an internal trigger mechanism that is a one-way valve housed within the handle section; its grant face records 313 days of patent term adjustment.

US 10,568,785 B2 The single-use head is keyed to this… (Medaxis AG, 'Protective cover', 18 claims) has independent claims 1, 8 and 13, each reciting a protective cover with a fluid-tight and flexible hollow body defining a treatment chamber whose shape adapts to the motion of a handpiece, a first opening to be placed on a body part of a patient, a second opening adapted for insertion of a handpiece, at least one stiffening element of elastically resilient material keeping the first opening open, and a transparent plate covering the smaller (claims 1 and 8) or second (claim 13verified) opening; its application 15/235,368 was filed 2016-08-12 claiming only foreign (EP) priority, with 779 days of patent term adjustment, so its statutory term runs to about 2038-09-30, later than the INPADOC naive 2036-08-12.

US 10,398,811 B1 US hospitals ('Medical irrigation system', University of Nebraska, INPADOC naive term to 2037-07-28) and US 11,504,457 B2 The single-use head is keyed to this… ('Wound irrigation system', family of US 2021/0228786 A1 Assumption, applicant Travis L. Perry, INPADOC naive term to 2040-10-28) are each recorded in INPADOC as in force; the claims of neither have been read.

US 2025/0082838 A1 Assumption, a continuation in the CareFusion family of US 12,178,977 B2 The single-use head is keyed to this… ('Lavage systems and devices having warming component'), is recorded in INPADOC as pending, with no grant, abandonment or lapse event on record; and US 2025/0375566 A1 Assumption, the US member of CareFusion's CA 3259785 A1 Assumption family ('Flow interface apparatus usable with wound irrigation device'), is recorded in INPADOC as pending; the claims of neither have been read.