510(k) · Cleared

Cleared

Oculus Microcyn Wound Gel

K090725510(k) TraditionalCleared May 20, 200962-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Oculus Innovative Sciences, Inc. · FRO Dressing, Wound, Drug

Cleared on May 20, 2009 as substantially equivalent to K020325 (L.A.M. Pharmaceutical, Corp., 2002) after a 62-day review. Its family tree reaches back 3 generations to 1983. 56 later devices descend from it.

Decided: May 20, 2009
Review: 62 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K830708 (1983). 6 ancestors in all. 56 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
2 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
1 generation backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
This deviceK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
Descendant · cites it directly · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
Descendant · 2 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
Descendant · cites it directly · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
Descendant · cites it directly · 20 of its ownK093697 Vashe Wound Therapy SolutionPuricore, Inc. · 2010
Descendant · 2 generations on · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2010high 9 (2026) · low 0 (2021)2026

Most influential descendants

Showing 5 of 56 · See all

K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · cites it directly31descendants
K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 2 generations on25descendants
K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · cites it directly25descendants
K093697Vashe Wound Therapy SolutionPuricore, Inc. · 2010 · cites it directly20descendants
K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · 2 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K830708	Duo Derm Flex Hydroactive Dressings &	Convatec, A Division of E.R. Squibb & Sons	1983	—
−2	K984413	Bionect Hydrogel	Fidia Pharmaceutical Corp.	1999	—
−1	K020325	L.a.M. Ipm Wound Gel	L.A.M. Pharmaceutical, Corp.	2002	—
0 (this device)	K090725	Oculus Microcyn Wound Gel	Oculus Innovative Sciences, Inc.	2009	—
+1	K100918	Vashe Wound Therapy System Model: 9000-0014	Puricore, Inc.	2010	—
+2	K123072	Vashe Wound Therapy Solution	Puricore, Inc.	2013	—
+1	K093585	Microcyn Skin and Wound Hydrogel	Oculus Innovative Sciences, Inc.	2010	1
+1	K093697	Vashe Wound Therapy Solution	Puricore, Inc.	2010	—
+2	K102945	Pediacyn Atopic Dermatitis Hydrogel	Oculus Innovative Sciences, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	4	0
2011	1	0
2012	1	0
2013	3	0
2014	5	0
2015	7	0
2016	3	0
2017	3	0
2018	4	0
2019	2	0
2020	1	0
2022	2	0
2023	2	0
2024	5	0
2025	4	0
2026	9	0

FIG. 1 — Lineage of K090725, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020325	L.a.M. Ipm Wound Gel Summary page 1 …ing cleared predicate device: LAM I.P.M.TM Wound Gel Cleanser originally manufactured by L.A.M Pharmaceutical Corp., cleared for distribution under 510(k) K020325. 5.4 Device Description Oculus MicrocynTM Skin and Wound Gel is a clear viscous, odorless, aqueous hydrogel. T…	L.A.M. Pharmaceutical, Corp.	2002	—

Also cleared against K020325: 3 other devices →

What descends from it? (56)

See all 56

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100918	Vashe Wound Therapy System Model: 9000-0014	Puricore, Inc.	2010	31
K093585	Microcyn Skin and Wound Hydrogel	Oculus Innovative Sciences, Inc.	2010	25
K093697	Vashe Wound Therapy Solution	Puricore, Inc.	2010	20
K093155	Vashe Wound Cleansing System	Puricore, Inc.	2010	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 26 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K100918 (Puricore, Inc., 2010) has gone furthest, with 31 descendants of its own.
3 other devices also cite its predicate K020325.

How does its category compare?

All FRO devices

FRO 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

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)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: Oculus Microcyn Skin and Wound Gel is intended for OTC use for the management of minor skin abrasions, lacerations, cuts and intact skin.

Professional Use: Under the supervision of a health care professional, Oculus Puracyn Wound Gel is intended for the management of exuding wounds such as leg ulcers, pressure ulcer, 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/K090725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090725: Oculus Microcyn Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090725

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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