510(k) · Cleared
Recalled · 2011Oculus Puracyn Antimicrobial Skin and Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 2, 2009 as substantially equivalent to K073547 (Anacapa Technologies, Inc., 2008) after a 125-day review. Its family tree reaches back 6 generations to 1992. 37 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 2, 2009
- Review
- 125 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 26 ancestors in all, the oldest K890354 (1989). 37 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 2 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 1 generation backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- This deviceK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009
- Descendant · cites it directly · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 2 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- Descendant · cites it directly · 20 of its ownK093697 Vashe Wound Therapy SolutionPuricore, Inc. · 2010
- Descendant · cites it directly · 15 of its ownK113693 Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012
- Descendant · cites it directly · 15 of its ownK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · cites it directly31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 2 generations on25descendants
- K093697Vashe Wound Therapy SolutionPuricore, Inc. · 2010 · cites it directly20descendants
- K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012 · cites it directly15descendants
- K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −1 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| 0 (this device) | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | — |
| +1 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +2 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| +1 | K093697 | Vashe Wound Therapy Solution | Puricore, Inc. | 2010 | — |
| +1 | K113693 | Nixall TM Wound and Skin Care | Seriously Clean, Ltd. | 2012 | — |
| +1 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 1…te device: Anasept TM Antimicrobial Skin and Wound Cleanser manufactured by Anacapa Technologies, cleared for distribution under 5 10(k) K073547. 5.4 Device Description Oculus Puracyn TM Skin and Wound Cleanser with Preservatives is a clear… | 2008 |
What descends from it? (37)
See all 378 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100918 | Vashe Wound Therapy System Model: 9000-0014 | 2010 | 31 |
| K093697 | Vashe Wound Therapy Solution | 2010 | 20 |
| K113693 | Nixall TM Wound and Skin Care | 2012 | 15 |
| K113820 | Neutrophase Antimicrobial Wound Cleanser | 2012 | 15 |
| K142592 | CleanSmart Wound Cleanser | 2015 | 4 |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | 2017 | 3 |
| K131542 | Neutrophase (R) Skin and Wound Cleanser Otc | 2013 | 3 |
| K093155 | Vashe Wound Cleansing System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2011 | Not classified | Z-0448-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
| Nov 9, 2011 | Not classified | Z-0449-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
| Nov 9, 2011 | Not classified | Z-0450-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K100918 (Puricore, Inc., 2010) has gone furthest, with 31 descendants of its own.
- 16 other devices also cite its predicate K073547.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management, via debridement of wounds such as stage I-IV pressure 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/K090206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090206: Oculus Puracyn 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/K090206
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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