510(k) · Cleared
ClearedModification to:Vashe Wound Cleansing System, Model 9000-0014
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 Aug 19, 2009 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 4 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1995. 16 later devices descend from it.
- Decided
- Aug 19, 2009
- Review
- 27 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K945802 (1995). 9 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 1 generation backK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
- This deviceK092232 Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK113693 Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012
- Descendant · 2 generations on · 14 of its ownK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- Descendant · 2 generations on · 4 of its ownK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012 · cites it directly15descendants
- K133542Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014 · 2 generations on14descendants
- K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019 · 3 generations on5descendants
- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · 4 generations on4descendants
- K142592CleanSmart Wound CleanserSimple Science, LLC · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −3 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −2 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −1 | K042729 | Dermacyn Wound Irrigation | Oculus Innovative Sciences, Inc. | 2005 | — |
| 0 (this device) | K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | Puricore, Inc. | 2009 | — |
| +1 | K113693 | Nixall TM Wound and Skin Care | Seriously Clean, Ltd. | 2012 | — |
| +2 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| +3 | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| +4 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +2 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K965120 | Allclenz Wound CleanserSummary page 1…mmon Name Wound Cleanser Classification Name Solution, saline, (wound dressing) Predicate Device AllklenzTM Cleanser; Healthpoint Medical K965120, March 21st 1997. CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670,… | 1997 |
| * | K022670 | Carraklenz and UltraklenzSummary page 1…e Device AllklenzTM Cleanser; Healthpoint Medical K965120, March 21st 1997. CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct. 17th, 2002. DermacynTM Wound Cleanser, Oculus Innovative Sciences, K0… | 2002 |
| * | K042729 | Dermacyn Wound IrrigationSummary page 1…ser; Carrington Laboratories, Inc. K022670, Oct. 17th, 2002. DermacynTM Wound Cleanser, Oculus Innovative Sciences, K042729, September 30th, 2004 and DermacynTM Wound Dressing, Oculus Innovative Sciences, K041161, February 1st… | 2005 |
| * | K041161 | Microcyn Wound Care DressingSummary page 1…culus Innovative Sciences, K042729, September 30th, 2004 and DermacynTM Wound Dressing, Oculus Innovative Sciences, K041161, February 1st, 2005. BiopureTM MTADTM Root Canal Cleanser, Dentsply International,… | 2005 |
| * | K053167 | Biopure Mtad Root Canal CleanserSummary page 1…lus Innovative Sciences, K041161, February 1st, 2005. BiopureTM MTADTM Root Canal Cleanser, Dentsply International, K053167, December 8, 2005 Description The subject device is a wound cleansing and disinfecting solution that is… | 2005 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113693 | Nixall TM Wound and Skin Care | 2012 | 15 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K113693 (Seriously Clean, Ltd., 2012) has gone furthest, with 15 descendants of its own.
- 7 other devices also cite its predicate K965120.
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?
Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree bums, abrasions and minor irritations of the skin in, addition to moistening and lubricating absorbent wound dressings.
The Vashe® Wound Cleanser is intended for used by qualified health care personnel trained in its use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092232: Modification to:Vashe Wound Cleansing System, Model 9000-0014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092232
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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