510(k) · Cleared
ClearedNeutrophase Antimicrobial Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabay Pharmaceuticals · FRO Dressing, Wound, Drug
Cleared on Aug 8, 2012 as substantially equivalent to K081009 (Novabay Pharmaceuticals, 2008) and 3 other predicates after a 225-day review. Its family tree reaches back 8 generations to 1992. 15 later devices descend from it.
- Decided
- Aug 8, 2012
- Review
- 225 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K914579 (1992). 38 ancestors in all, the oldest K830708 (1983). 15 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 4 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 3 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 2 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 1 generation backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- This deviceK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- Descendant · cites it directly · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · 2 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · cites it directly · 3 of its ownK131542 Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · cites it directly8descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 2 generations on4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 2 generations on3descendants
- K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013 · cites it directly3descendants
- K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −4 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −2 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −1 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| 0 (this device) | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| +1 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +2 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +2 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +1 | K131542 | Neutrophase (R) Skin and Wound Cleanser Otc | Novabay Pharmaceuticals, Inc. | 2013 | — |
| +1 | K141660 | Nawalution Skin and Wound Cleanser | Nawa Heilmittel GmbH | 2014 | — |
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 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K081009 | NeutrophaseSummary page 1…Unclassified Classification Panel: General and Plastic Surgery A. Legally Marketed Predicate Devices The modified device is substantially equivalent to NeutroPhase (K081009), also manufactured by NovaBay Pharmaceuticals, Inc., Vashe Wound Therapy+ Solution manufactured by PuniCore (K1 00918), Oculus P… | 2008 |
| * | K100918 | Vashe Wound Therapy System Model: 9000-0014Summary page 1…device is substantially equivalent to NeutroPhase (K081009), also manufactured by NovaBay Pharmaceuticals, Inc., Vashe Wound Therapy+ Solution manufactured by PuniCore (K1 00918), Oculus Puracyn Antimicrobial Skin and Wound Cleanser manufactured by Oculus Innovative Sciences (K090206) and Anasept Antimicro… | 2010 |
| * | K090206 | Oculus Puracyn Antimicrobial Skin and Wound CleanserSummary page 1…Inc., Vashe Wound Therapy+ Solution manufactured by PuniCore (K1 00918), Oculus Puracyn Antimicrobial Skin and Wound Cleanser manufactured by Oculus Innovative Sciences (K090206) and Anasept Antimicrobial Wound Cleanser (K073547), manufactured by Anacapa Technologies, Inc. B. Device Description: NeutroPh… | 2009 |
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 1…PuniCore (K1 00918), Oculus Puracyn Antimicrobial Skin and Wound Cleanser manufactured by Oculus Innovative Sciences (K090206) and Anasept Antimicrobial Wound Cleanser (K073547), manufactured by Anacapa Technologies, Inc. B. Device Description: NeutroPhase Skin and Wound Cleanser is a clear, liquid solu… | 2008 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | 2014 | 8 |
| K131542 | Neutrophase (R) Skin and Wound Cleanser Otc | 2013 | 3 |
| K141660 | Nawalution Skin and Wound Cleanser | 2014 | 2 |
| K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) | 2018 | 0 |
| K151168 | Nexodyn AOS Wound Care Solution | 2015 | 0 |
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 20 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 38 ancestors has a recall of any class.
- Of its descendants, K131848 (Puricore, Inc., 2014) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including micro-organisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113820: Neutrophase Antimicrobial 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/K113820
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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