510(k) · Cleared
ClearedPuracyn Plus Skin and Wound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovacyn, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 28, 2014 as substantially equivalent to K093697 (Puricore, Inc., 2010) and 2 other predicates after a 161-day review. Its family tree reaches back 9 generations to 1992. 14 later devices descend from it.
- Decided
- Apr 28, 2014
- Review
- 161 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K914579 (1992). 43 ancestors in all, the oldest K830708 (1983). 14 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations between
- 3 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 2 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 1 generation backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- This deviceK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- Descendant · cites it directly · 4 of its ownK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · 2 generations on · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
Show all 9 generations
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 7 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 6 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 5 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 4 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 3 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 2 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 1 generation backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- This deviceK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019 · cites it directly5descendants
- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · 2 generations on4descendants
- K142592CleanSmart Wound CleanserSimple Science, LLC · 2015 · cites it directly4descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 3 generations on3descendants
- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −8 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −7 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −6 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −5 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −3 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −2 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −1 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| 0 (this device) | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| +1 | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| +2 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +1 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| +3 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +2 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
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 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K093697 | Vashe Wound Therapy SolutionSummary page 1…Classification Panel: General and Plastic Surgery 5.3 Identification of Legally Marketed Device for Substantial Equivalence Comparison: K093697: Vashe® Wound Therapy Solution (OTC use) manufactured by PurlCore, Inc. K 123072:… | 2010 |
| * | K123072 | Vashe Wound Therapy SolutionSummary page 1…Substantial Equivalence Comparison: K093697: Vashe® Wound Therapy Solution (OTC use) manufactured by PurlCore, Inc. K 123072: Vashe® Wound Therapy Solution (Professional use) manufactured by PuniCore, Inc. KI 13… | 2013 |
| * | K113693 | Nixall TM Wound and Skin Care | 2012 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K181428 (Clyra Medical Technologies, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K093697.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
OTC: Puracyn PlusTM Skin and Wound Care is intended for the OTC use of the management of minor skin wounds including minor lacerations, minor abrasions, minor irritations, minor cuts, minor burns and intact skin, in addition to moistening and lubricating absorbent wound dressings. Professional Use: Puracyn PlusTM Skin and Wound Care is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris…
Read the full statement (118 words)
OTC: Puracyn PlusTM Skin and Wound Care is intended for the OTC use of the management of minor skin wounds including minor lacerations, minor abrasions, minor irritations, minor cuts, minor burns and intact skin, in addition to moistening and lubricating absorbent wound dressings.
Professional Use: Puracyn PlusTM Skin and Wound Care is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133542: Puracyn Plus Skin and Wound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133542
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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