510(k) · Cleared
ClearedVashe Skin and Wound Hydrogel
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 Jan 24, 2013 as substantially equivalent to K102945 (Oculus Innovative Sciences, Inc., 2011) after a 115-day review. Its family tree reaches back 6 generations to 1983. 11 later devices descend from it.
- Decided
- Jan 24, 2013
- Review
- 115 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K830708 (1983). 16 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 5 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 4 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 3 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 2 generations backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- 1 generation backK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- This deviceK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- Descendant · 2 generations on · 9 of its ownK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- Descendant · 4 generations on · 2 of its ownK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- Descendant · 5 generations on · 1 of its ownK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · cites it directly10descendants
- K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc. · 2015 · 2 generations on9descendants
- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · 3 generations on3descendants
- K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018 · 4 generations on2descendants
- K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −5 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −4 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −3 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| −1 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| 0 (this device) | K123071 | Vashe Skin and Wound Hydrogel | Puricore, Inc. | 2013 | — |
| +1 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| +2 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +3 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| +4 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| +5 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K102945 | Pediacyn Atopic Dermatitis HydrogelSummary page 1…nd Dressing Classification Dressing, wound and burn drug/hydrogel Name Predicate Devices Epicyn Tm HydroGel, Oculus Innovative Sciences, Inc., K102945, February 2nd, 2011. Device Description VasheO Skin and Wound Hydrogel isan emollient containing, non oily hydrogel.… | 2011 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141863 | Puricore Wound Hydrogel Spray Dressing | 2015 | 10 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K141863 (Puricore, Inc., 2015) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K102945.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Vashel Skin and Wound Hydrogel - For Professional Use Only
Under the supervision of a health care professional, Vashel Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123071: Vashe Skin and Wound Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123071
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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