510(k) · Cleared
Clearedrevyve® Antimicrobial Skin and Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kane Biotech, Inc. · FRO Dressing, Wound, Drug
Cleared on Jan 8, 2026 as substantially equivalent to K160192 (Rochal Industries, LLC, 2016) and 1 other predicate after a 132-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Jan 8, 2026
- Review
- 132 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K914579 (1992). 53 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 11 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations between
- 3 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 2 generations backK131542 Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
- 1 generation backK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
- This deviceK252759 revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 10 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 9 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 8 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 7 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 6 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 5 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 4 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 3 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 2 generations backK131542 Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
- 1 generation backK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
- This deviceK252759 revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −10 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −9 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −8 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −7 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −6 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −5 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −4 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −3 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| −2 | K131542 | Neutrophase (R) Skin and Wound Cleanser Otc | Novabay Pharmaceuticals, Inc. | 2013 | — |
| −1 | K141660 | Nawalution Skin and Wound Cleanser | Nawa Heilmittel GmbH | 2014 | — |
| 0 (this device) | K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 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? (2)
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 |
|---|---|---|---|
| * | K160192 | Atteris Antimicrobial Skin & Wound CleanserSummary page 5…ifica on Name: Unclassified Regulatory Class: Unclassified Product Code: FRO III PREDICATE DEVICES Primary Predicate: A eris™ (BIAKOS) An microbial Skin & Wound Cleanser (K160192) Secondary Predicate: NAWAlu on Skin and Wound Cleanser (K141660) IV DEVICE DESCRIPTION revyve® An microbial Skin and Wound C… | 2016 |
| * | K141660 | Nawalution Skin and Wound CleanserSummary page 5…de: FRO III PREDICATE DEVICES Primary Predicate: A eris™ (BIAKOS) An microbial Skin & Wound Cleanser (K160192) Secondary Predicate: NAWAlu on Skin and Wound Cleanser (K141660) IV DEVICE DESCRIPTION revyve® An microbial Skin and Wound Cleanser is a clear, colorless liquid containing poloxamer 407, EDT… | 2014 |
| † | K241809 | coactiv+™ Antimicrobial Wound Gel | 2024 |
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 34 years and passes through 11 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 53 ancestors has a recall of any class.
- 2 other devices also cite its predicate K160192.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second…
Read the full statement (120 words)
Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions.
OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252759: revyve® Antimicrobial Skin and Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252759
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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