510(k) · Cleared
ClearedPuracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula
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 Nov 19, 2015 as substantially equivalent to K093585 (Oculus Innovative Sciences, Inc., 2010) and 3 other predicates after a 238-day review. Its family tree reaches back 8 generations to 1992. 9 later devices descend from it.
- Decided
- Nov 19, 2015
- Review
- 238 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K914579 (1992). 48 ancestors in all, the oldest K830708 (1983). 9 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 4 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 3 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 2 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 1 generation backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- This deviceK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK254041 SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · cites it directly3descendants
- K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018 · 2 generations on2descendants
- K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024 · 3 generations on1descendant
- K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017 · cites it directly1descendant
- K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −4 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −2 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −1 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| 0 (this device) | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +1 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| +2 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| +3 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| +1 | K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017 | — |
| +1 | K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K093585 | Microcyn Skin and Wound HydrogelSummary page 4…e following devices as related to intended use, design, and material characteristics: • Microcyn™ Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc., K093585 • Anasept™ Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073547 • Puricore Wound Hydrogel Spray… | 2010 |
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 4…Microcyn™ Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc., K093585 • Anasept™ Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073547 • Puricore Wound Hydrogel Spray Dressing, Puricore Inc., K141863 • Epicyn™ HydroGel, Oculus Innovative Sciences, Inc.,… | 2008 |
| * | K141863 | Puricore Wound Hydrogel Spray Dressing Cleared while this submission was under review Summary page 4…K093585 • Anasept™ Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073547 • Puricore Wound Hydrogel Spray Dressing, Puricore Inc., K141863 • Epicyn™ HydroGel, Oculus Innovative Sciences, Inc., K102945 Innovacyn’s Puracyn Plus Skin and Wound Care Solutions (K1335… | 2015 |
| * | K102945 | Pediacyn Atopic Dermatitis HydrogelSummary page 4…acapa Technologies, Inc., K073547 • Puricore Wound Hydrogel Spray Dressing, Puricore Inc., K141863 • Epicyn™ HydroGel, Oculus Innovative Sciences, Inc., K102945 Innovacyn’s Puracyn Plus Skin and Wound Care Solutions (K133542) is used as a reference device. Description of the Device Pura… | 2011 |
| † | K133542 | Puracyn Plus Skin and Wound | 2014 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial… | 2016 | 3 |
| K171935 | Alevicyn SG Antimicrobial Gel | 2017 | 1 |
| K254041 | SkinSmart Antimicrobial HydroGel | 2026 | 0 |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | 2025 | 0 |
| K212521 | Field Shield Wound Dressing | 2024 | 0 |
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 23 years and passes through 8 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 48 ancestors has a recall of any class.
- Of its descendants, K160095 (Simple Science, LLC, 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K093585.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to…
Read the full statement (190 words)
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150799
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