510(k) · Cleared
Recalled · 2011Microcyn Skin and Wound Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Mar 8, 2010 as substantially equivalent to K090092 (Mcmerlin Dental Products LP, 2009) and 1 other predicate after a 109-day review. Its family tree reaches back 4 generations to 1983. 25 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2010
- Review
- 109 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K830708 (1983). 12 ancestors in all. 25 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 3 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 2 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 1 generation backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- This deviceK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- Descendant · 2 generations on · 11 of its ownK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK153648 Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · cites it directly17descendants
- K123071Vashe Skin and Wound HydrogelPuricore, Inc. · 2013 · 2 generations on11descendants
- 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 · cites it directly9descendants
- K153648Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences · 2016 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −3 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −2 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −1 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| 0 (this device) | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | — |
| +1 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| +2 | K123071 | Vashe Skin and Wound Hydrogel | Puricore, Inc. | 2013 | — |
| +1 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| +1 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +1 | K153648 | Microcyn Plus Skin and Wound Hydrogel | Oculus Innovative Sciences | 2016 | — |
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 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K090092 | Sockit! and Mcmerlin Dermal Wound GelSummary page 1…ocklt!~ Dermal Wound Gel/McMerlin®~ Dermal Wound G61 manufactured by McMerlin Dental Products, LP. cleared for distribution via 510O(k) K090092 on September 9. 2009. o Oculus Microcyn Skin and Wound Gel manufactured by Oculus Innovative Sci… | 2009 |
| * | K090725 | Oculus Microcyn Wound GelSummary page 1…September 9. 2009. o Oculus Microcyn Skin and Wound Gel manufactured by Oculus Innovative Sciences, cleared for distribution via 5 10(k) K090725 on May 122, 2009 (Appendfix 3)… | 2009 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102945 | Pediacyn Atopic Dermatitis Hydrogel | 2011 | 17 |
| K141863 | Puricore Wound Hydrogel Spray Dressing | 2015 | 10 |
| K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus… | 2015 | 9 |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | 2016 | 6 |
| K240510 | Microdacyn Hydrogel | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2011 | Not classified | Z-0451-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K102945 (Oculus Innovative Sciences, Inc., 2011) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K090092.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
OTC: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores…
Read the full statement (109 words)
OTC:
Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn.
Professional Use:
Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093585: Microcyn Skin and Wound Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093585
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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