510(k) · Cleared

Cleared

Sockit! and Mcmerlin Dermal Wound Gel

K090092510(k) TraditionalCleared May 11, 2009117-day reviewClass U

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

Mcmerlin Dental Products LP · FRO Dressing, Wound, Drug

Cleared on May 11, 2009 as substantially equivalent to K902345 (Carrington Laboratories, Inc., 1990) and 4 other predicates after a 117-day review. Its family tree reaches back 1 generation to 1990. 26 later devices descend from it.

Decided: May 11, 2009
Review: 117 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K902345 (1990). 5 ancestors in all. 26 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK902345 Carrington Wound DressingCarrington Laboratories, Inc. · 1990
This deviceK090092 Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP · 2009
Descendant · cites it directly · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
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 · 2 generations on · 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

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2010high 5 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 26 · See all

K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · cites it directly25descendants
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 · 2 generations on10descendants
K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc. · 2015 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902345	Carrington Wound Dressing	Carrington Laboratories, Inc.	1990	—
0 (this device)	K090092	Sockit! and Mcmerlin Dermal Wound Gel	Mcmerlin Dental Products LP	2009	—
+1	K093585	Microcyn Skin and Wound Hydrogel	Oculus Innovative Sciences, Inc.	2010	1
+1	K102945	Pediacyn Atopic Dermatitis Hydrogel	Oculus Innovative Sciences, Inc.	2011	—
+2	K123071	Vashe Skin and Wound Hydrogel	Puricore, Inc.	2013	—
+2	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
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

FIG. 1 — Lineage of K090092, 1990–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K902345	Carrington Wound Dressing Summary page 1 …Code Mauatrr Panel Carrington Carrington General & K902345 Wound FRO Laboratories, Plastic Dressing…	Carrington Laboratories, Inc.	1990	—
*	K915002	Sterile Gauze PK Strips Sat W/Carr Gel Wound Dress Summary page 1 …nc. Surgery Carrasyn Hydrogel Carrington General & K91 5002 Wound MGQ Laboratories, Plastic Dressing…	Carrington Laboratories, Inc.	1992	—
*	K944427	Carrasyn FDG Summary page 1 …ugr [Carragauze Ic ugr ______ ___ PADS] K944427 Carrasyn FDG MGQ ~~Carrington General & K9444…	Carrington Laboratories, Inc.	1994	—
*	K951417	Carrasyn Hydrogel Wound Dressing, FDG Pads, Carragauze Pads, Strips Summary page 1 …_________ Surgery Carrasyn Hydrogel General & K951417 Wound M Carrington Plastic Dressing…	Carrington Laboratories, Inc.	1995	—
*	K961758	Carasyn Hydrogel Wound Products Summary page 1 …ragauze FDG Pads] _____ Carrasyn General & K961758 ydrgelCarrington Plsc K9617H8droged…	Carrington Laboratories, Inc.	1996	—

Also cleared against K902345: 3 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K093585	Microcyn Skin and Wound Hydrogel	Oculus Innovative Sciences, Inc.	2010	25
K102945	Pediacyn Atopic Dermatitis Hydrogel	Oculus Innovative Sciences, Inc.	2011	17
K153648	Microcyn Plus Skin and Wound Hydrogel	Oculus Innovative Sciences	2016	6
K173549	Biafine	Valeant Pharmaceuticals	2018	4

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?

None of the 5 ancestors has a recall.
Of its descendants, K093585 (Oculus Innovative Sciences, Inc., 2010) has gone furthest, with 25 descendants of its own.
3 other devices also cite its predicate K902345.

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?

This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include: All types of dermal wounds, skin sores, injuries and ulcers of the skin First & Second degree burns Pressure ulcers, stages I — IV Stasis ulcers Diabetic ulcers Radiation dermatitis Post-surgical incision Surgical sites, including soft tissue graft sites Foot ulcers Venous stasis…

Read the full statement (176 words)

This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include:

All types of dermal wounds, skin sores, injuries and ulcers of the skin

First & Second degree burns

Pressure ulcers, stages I — IV

Stasis ulcers

Diabetic ulcers

Radiation dermatitis

Post-surgical incision

Surgical sites, including soft tissue graft sites

Foot ulcers

Venous stasis ulcers

Cuts & Abrasions

Partial thickness wounds

Irritation of the skin

Itching

Sunburn

Skin condition associated periostomy care

Chemical peel

Tattooing procedures

Irritation and pain following skin Laser resurfacing treatment

Irritation and pain following dermabrasion therapy

This product provides for the management of and relieves the pain associated with all minor dermal wounds, minor skin sores, minor injuries and minor irritations of the skin. Examples include:

Minor burns

Minor Cuts & Abrasions

Superficial itching

Sunburn

Minor burns from a chemical peel treatment

Minor irritation and pain following tattooing procedures

Minor irritation and pain following skin laser resurfacing treatment

Minor irritation and pain following dermabrasion therapy

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K090092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090092: Sockit! and Mcmerlin Dermal 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/K090092

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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