510(k) · Cleared
ClearedArmis VeriCyn Wound Wash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armis Biopharma, Inc. · FQH Lavage, Jet
Cleared on May 25, 2023 as substantially equivalent to K161165 (Next Science, LLC, 2016) after a 436-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 25, 2023
- Review
- 436 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945802 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 5 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 4 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 3 generations backK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- 2 generations backK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- 1 generation backK161165 Next Science Irrigation SolutionNext Science, LLC · 2016
- This deviceK220759 Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −5 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −4 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −3 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| −2 | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| −1 | K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016 | — |
| 0 (this device) | K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161165 | Next Science Irrigation SolutionSummary page 4…CFR 880.5475 Device Classification FQH / FRO / General Hospital Lavage, Jet VeriCyn® Wound Wash Predicate Device K161165 Next Science™ Irrigation Solution K151186 Stay Fresh Hydrocolloid Dressing Reference Device… | 2016 |
| † | K151186 | Stay Fresh Hydrocolloid dressing | 2015 |
| † | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 5.6 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K161165.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including micro-organisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220759: Armis VeriCyn Wound Wash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026