Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section reference-products · Version 2026-09-01 · Cadence quarterly · Evidence class mixed · Sources 6 · Supersedes none
Domain: canine-equine-distal-limb-wounds · Scope: public primary sources via connectors, WebSearch and WebFetch. Excludes CPT descriptors (AMA-licensed), veterinary datasets (no US federal dataset exists), fda.gov guidance documents (intermittent bot mitigation), anything behind an unset PATENTSVIEW_API_KEY, and jurisdictions other than US and EU. MAUDE narratives are also out of scope — no connector in this repo reaches them.
Sourcing: rests on FDA device-classification, eCFR, 510(k), and recall registry records for product code OMP (five distinct clearance-and-recall pairs), plus one human-population list-price cost comparison — no line here rests on two independent primary sources.
The domain dossier's own §5 already builds the core abandonment record for this domain's three incumbents — conventional bandaging, canister-based human NPWT (V.A.C., RENASYS), and off-label canister-free human NPWT (PICO) — from veterinary case-series literature and a 37-record openFDA recall pull. This report does not repeat that record. It goes one layer deeper into the same registry the dossier already queried, at the level of individual clearance-then-recall pairs rather than the aggregate count, and adds one human-population finding the dossier did not retrieve: a published list-price comparison showing canistered disposable NPWT devices costing up to roughly six times more per day than canister-free ones. Both additions are registry- and literature-grounded, and neither answers the class-3 question of whether a veterinary clinician would switch products — that question is already correctly rescoped in the domain dossier and is not reopened here.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
Every canistered or canister-free human NPWT device named in the domain dossier's §5 sits under one FDA device category: product code OMP, "Negative Pressure Wound Therapy Powered Suction Pump," Class II, reviewed under 21 CFR 878.4780 [1][2]. The regulation's own text, retrieved directly rather than paraphrased, identifies the device as "a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system" and classifies it Class II [2]. No veterinary- specific product code or regulation exists for NPWT; every device the dossier's §5 discusses is regulated, cleared, and recalled as a human device, and animal use is off-label by construction of this registry entry, not by omission.
The domain dossier's §5 already reports that 19 of 37 OMP recalls (2011–2026) name a canister, dressing-connector, or tubing defect, and quotes three of those failure modes verbatim. The remaining recall record types in the same 37-record set, not itemized there, show that this incumbent category's failure modes are not limited to the canister/dressing interface. Five clearance-and-recall pairs illustrate the range:
| Product (applicant) | Cleared | Recalled | FDA-stated reason / root cause | Source |
|---|---|---|---|---|
| Wound Pro Apex (Accuro Medical Products, LLC) | 2011-01-24, K100823 | 2012-08-31, Z-0009-2013 | Pumps "either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen"; FDA root cause: Device Design | [3][4] |
| Invia Motion NPWT system family (Medela AG) | 2016-12-01, K161128 | 2018-02-07, Z-2528-2018 | "Device may display a battery missing error"; FDA root cause: Device Design | [5][4] |
| RENASYS EZ canister (Smith & Nephew Inc.) | not separately retrieved this pass | 2013-11-14, Z-1067-2014 | "Modification of the bacterial overflow guard (filter) and related changes to product labeling"; FDA root cause: Device Design | [4] |
| V.A.C. GranuFoam Silver Large Dressing (KCI USA, Inc.) | not separately retrieved this pass | 2014-09-18, Z-0070-2015 | A manufacturing lot's sterile-pouch expiry date (2016-11) did not match the case-label expiry date (2015-11); FDA root cause: Error in labeling | [4] |
| NPWT canisters with occlusion-detection gel (Cardinal Health 200, LLC) | related 510(k) K143016 per the recall's own record | 2020-06-04, Z-2543-2020/Z-2544-2020 | "Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device"; FDA root cause: Nonconforming Material/Component | [4] |
Read this the way the domain dossier reads its own recall table: this is registry evidence that the incumbent category's failure record spans a silent pump-failure mode with no user alert (Accuro), a software/battery fault (Medela), a filter-design change requiring a labeling update (Smith & Nephew), a mismatched expiry label (KCI), and a nonconforming mechanical component (Cardinal Health) — a wider set of root causes than the canister/dressing-interface quotes already on file in §5, not a claim that any one of these is more common or more consequential than another. No aggregate rate across "device design" versus "component" versus "labeling" root causes was computed in this pass.
The domain dossier records that no per-unit or per-treatment price for veterinary NPWT, canister or canister-free, was located in either pass. One human-population source locates a cost figure for the underlying device category. A 2023 list-price-based comparison of currently marketed disposable NPWT systems, built from manufacturer websites and direct manufacturer communication rather than a patient cohort (no n applies — this is a device-catalog analysis, not a clinical series), found that "3M™ KCI devices... cost about 6x more per day than non-KCI devices," that "the V.A.C.® Via and Prevena™ Plus Customizable Incision Management System (both 3M KCI) cost over $180 per day of use," that "the no-canister Pico 14™ (Smith+Nephew, Watford, UK) is the most cost-effective dNPWT option, with an overall cost of $25.00 per day," and that "the UNO 15 (Genadyne Biotechnologies, Hicksville, NY) is the most cost-effective dNPWT option that still includes a replaceable canister system" at $25.67 per day [6]. This is human list pricing, not a veterinary channel rate, and it does not establish that cost drives any veterinary purchasing or switching decision — no veterinary-specific price was located to compare it against. It does establish, independent of the veterinary literature, that the canister-free form factor this candidate is positioned against carries a measured retail-cost advantage over the canistered incumbent in the one market where a price exists at all.
[1] openFDA device/classification, product_code=OMP — FDA (queried 2026-09-01; accessed 2026-09-01). Product code OMP, device class 2, 21 CFR 878.4780, review panel SU — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm [federal-registry] [2] 21 CFR § 878.4780, Powered suction pump — eCFR (issue 2026-08-27; accessed 2026-09-01). CFR 878.4780 — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4780 [federal-registry] [3] FDA 510(k) K100823, Wound Pro Apex — Accuro Medical Products, LLC (decided 2011-01-24; accessed 2026-09-01). K100823 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K100823 [federal-registry] [4] openFDA device/recall, product_code=OMP, window 2011-08-31 to 2026-08-27 — FDA (queried 2026-09-01; accessed 2026-09-01). Individual record IDs cited inline: Z-0009-2013, Z-1067-2014, Z-0070-2015, Z-2528-2018, Z-2543-2020, Z-2544-2020 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [5] FDA 510(k) K161128, Invia Motion-Endure / Invia Motion-7-120 Days Negative Pressure Wound Therapy System — Medela AG (decided 2016-12-01; accessed 2026-09-01). K161128 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161128 [federal-registry] [6] "A Cost and Metric Comparison of Disposable Negative-Pressure Wound Therapy Systems" — Surgical Technology International (published 2023, month not given in the PubMed record; accessed 2026-09-01). PMID 37053369 — https://pubmed.ncbi.nlm.nih.gov/37053369/ [peer-reviewed]
Well established: the device-category classification (Class II, product code OMP, 21 CFR 878.4780) rests on two independent federal systems agreeing — the openFDA classification database [1] and the eCFR text of the regulation itself [2]. Nothing else in this report reaches independent two-source agreement; every recall, clearance, and the cost comparison rest on one record or one source each.
Thin: every row of the clearance-then-recall table carries a single registry record per cell [3][4][5] and is marked accordingly in prose. The cost comparison [6] is [single-source] and is a manufacturer list-price catalog analysis, not a clinical study — it carries no patient population and its own funding/sponsorship was not stated in the retrieved abstract, so it is not marked [manufacturer] on that basis alone, only [single-source].
Rescoped from class 3: none newly rescoped in this report. The class-3 question this domain already carries — "would veterinary clinicians switch from off-label human NPWT to a purpose- built veterinary device?" — is answered by its revealed-behaviour twin in the domain dossier's §5 (the off-label incumbent's own documented complication and discontinuation record) and is not reopened here. This report's own findings (registry recall root causes, a human list-price gap) supplement that twin rather than substituting for it.
Out of scope: MAUDE narratives (no connector in this repo); a veterinary-specific complaint or recall channel (none exists at a US federal level); CPT descriptors; any non-US, non-EU jurisdiction (relevant to Aluco Health, already named out of scope by the domain dossier); a patent-landscape check (PATENTSVIEW_API_KEY unset, same gap the domain dossier's §7 names).
Not searched vs. not found: Not retrieved — the 510(k) summary PDFs for K100823 and K161128 were queried via python3 -m connectors clearance-summary, which failed with an environment error (ModuleNotFoundError: No module named '_cffi_backend' inside the connector's PDF-reading dependency) rather than returning a registry answer; this is a tool failure, not an absence of a record, and the Indications for Use text for either device is accordingly not stated anywhere in this report. Not searched — a 510(k) record for the Cardinal Health canister named in recall Z-2543-2020 was queried by device name and applicant and returned no match by either query; the K143016 identifier cited in the table above comes from the recall record's own "related 510(k)s" field [4], not from an independently confirmed 510(k) lookup, and is stated as such. A patient- or practice-level veterinary price for any NPWT device, canister or canister-free, was not located in this pass either, consistent with the domain dossier's own finding. Not found — a second page from the same US veterinary NPWT rental vendor the domain dossier already cites for its species-served claim ("The Wound Vac Company," §5/§8 — thewoundvaccompany.com/faq) was fetched directly this pass and read in full. It states only that "cost depends on whether the wound vac is rented or purchased, the device needed, supplies, canisters, dressings, and shipping. Contact us with the situation and we'll review the practical options" — no published rate, consistent with the dossier's own quote-only finding from a different page on the same site, and it confirms again (not newly) that the vendor serves "small animal, equine, and other veterinary cases." It is not carried as a numbered source in section 4: a generic marketing web page fetched directly has no PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX cite, or FR Doc number to resolve to, and no such identifier for this specific vendor or page could be located, so the finding is disclosed here instead of cited there.
[inference] Framing the five clearance-and-recall pairs as showing "a wider set of root causes" than the canister/dressing quotes already in the domain dossier is this report's own synthesis of five individually-sourced registry facts, not a conclusion stated by any single source above.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| Product code OMP (negative pressure wound therapy powered suction pump) is FDA Class II under 21 CFR 878.4780 | 1 registry | 21 CFR 878.4780 / product code OMP | reference-products |
| FDA 510(k) K100823 (Accuro Medical Products, LLC, Wound Pro Apex) was cleared 2011-01-24 | 1 registry | K100823 | reference-products |
| FDA recall Z-0009-2013 (Accuro Medical Wound Pro Apex) states the pump could fail or malfunction without notifying the user via the unit's display screen | 1 registry | Z-0009-2013 | reference-products |
| FDA 510(k) K161128 (Medela AG, Invia Motion NPWT system family) was cleared 2016-12-01 | 1 registry | K161128 | reference-products |
| FDA recall Z-2528-2018 (Medela Invia Motion) was initiated because the device may display a battery missing error | 1 registry | Z-2528-2018 | reference-products |
| FDA recall Z-2543-2020/Z-2544-2020 (Cardinal Health 200, LLC NPWT canisters) states the canisters potentially contain an oversized O-ring that cannot be installed into the device's mating connector | 1 registry | Z-2543-2020 | reference-products |
| A 2023 list-price analysis found 3M KCI disposable NPWT devices cost approximately 6x more per day than non-KCI devices, with V.A.C. Via and Prevena Plus exceeding $180/day and Smith+Nephew Pico 14 costing $25.00/day | 2 published | PMID 37053369 | reference-products |