510(k) · Cleared
ClearedVashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puricore, Inc. · FRO Dressing, Wound, Drug
Cleared on Mar 31, 2014 as substantially equivalent to K113820 (Novabay Pharmaceuticals, 2012) and 3 other predicates after a 283-day review. Its family tree reaches back 9 generations to 1992. 8 later devices descend from it.
- Decided
- Mar 31, 2014
- Review
- 283 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K914579 (1992). 54 ancestors in all, the oldest K830708 (1983). 8 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 backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- This deviceK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · cites it directly · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · cites it directly · 1 of its ownK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253665 Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
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 backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- This deviceK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · cites it directly4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · cites it directly3descendants
- K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025 · cites it directly1descendant
- K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · 2 generations on1descendant
- K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026 · cites it directly0descendants
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 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| 0 (this device) | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +1 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +1 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +1 | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 | — |
| +2 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
| +1 | K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 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 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K113820 | Neutrophase Antimicrobial Wound CleanserSummary page 1…ntially equivalent chemical composition, mechanical action, and labeling: Devices NeutroPhase Skin and Wound Cleanser®; NovaBay Pharmaceuticals, Inc. K113820, August 8t 2012; Vashe' Wound Therapy Solution; PuniCore Inc. K123072, February 14, 2013… | 2012 |
| * | K123072 | Vashe Wound Therapy SolutionSummary page 1…NeutroPhase Skin and Wound Cleanser®; NovaBay Pharmaceuticals, Inc. K113820, August 8t 2012; Vashe' Wound Therapy Solution; PuniCore Inc. K123072, February 14, 2013 Wound Wash Saline; Blairex Laboratories, Inc. K083355, December 29, 2008… | 2013 |
| * | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Summary page 1…Vashe' Wound Therapy Solution; PuniCore Inc. K123072, February 14, 2013 Wound Wash Saline; Blairex Laboratories, Inc. K083355, December 29, 2008 ExSept Skin and Wound Cleanser; Alcavis HDC LLC, K111313, December 14, 2011 Produc… | 2008 |
| * | K111313 | Exsept Skin and Wound Cleanser with Antimicrobial PreservativeSummary page 1…Wound Wash Saline; Blairex Laboratories, Inc. K083355, December 29, 2008 ExSept Skin and Wound Cleanser; Alcavis HDC LLC, K111313, December 14, 2011 Product ashe® Wound Solution is a saline based wound cleanser that contains hypochlorous a… | 2011 |
What descends from it? (8)
4 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 2.0 years on median.
- 2 of the 54 ancestors have a recall of any class.
- Of its descendants, K141012 (Oculus Innovative Sciences, 2014) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K113820.
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?
Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites; and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131848
Report an extraction error
Are you the manufacturer?
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