510(k) · Cleared
ClearedPuracyn® Plus Antimicrobial Irrigation Solution
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 Jan 5, 2026 as substantially equivalent to K232080 (Innovacyn, Inc., 2024) after a 210-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Jan 5, 2026
- Review
- 210 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K914579 (1992). 45 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 backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 2 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 1 generation backK232080 Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc. · 2024
- This deviceK251757 Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, 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 backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 2 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 1 generation backK232080 Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc. · 2024
- This deviceK251757 Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, 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 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −2 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −1 | K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2024 | — |
| 0 (this device) | K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, 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 |
| 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 |
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 |
|---|---|---|---|
| * | K232080 | Puracyn® Plus Antimicrobial Irrigation SolutionSummary page 5…on Name: Wound Irrigation Solution Product Code: FRO/FQH Device Classification Unclassified/ Class II (21 CFR 880.5475) Predicate Device: K232080, Puracyn® Plus Antimicrobial Irrigation Solution, Innovacyn, Inc. Device Description: Puracyn® Plus Antimicrobial Irrigation Sol… | 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 8 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 45 ancestors have a recall of any class.
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?
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation for mechanical cleansing and removal of debris from wounds, including microorganisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251757: Puracyn® Plus Antimicrobial Irrigation Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251757
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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