510(k) · Cleared

Cleared

Carrington Dermal Wound Gel

K894541510(k) TraditionalCleared Nov 30, 1989133-day reviewClass U

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

Carrington Laboratories, Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 30, 1989 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 115 later devices descend from it.

Decided: Nov 30, 1989
Review: 133 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

115 later devices descend from it, 3 citing it directly.

This deviceK894541 Carrington Dermal Wound GelCarrington Laboratories, Inc. · 1989
Descendant · cites it directly · 112 of its ownK991202 Modification to Woun'dresColoplast Corp. · 1999
Descendant · 2 generations on · 106 of its ownK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
Descendant · 2 generations on · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
Descendant · 3 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
Descendant · 4 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008

Showing 5 of 115 descendants. See all descendants

Descendants cleared per year

1998high 13 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 115 · See all

K991202Modification to Woun'dresColoplast Corp. · 1999 · cites it directly112descendants
K022995Collatek HydrogelBiocore Medical Technologies, Inc. · 2002 · 2 generations on106descendants
K040019SilversealNoble Fiber Technologies · 2004 · 2 generations on97descendants
K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 3 generations on73descendants
K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 4 generations on66descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K894541	Carrington Dermal Wound Gel	Carrington Laboratories, Inc.	1989	—
+1	K991202	Modification to Woun'dres	Coloplast Corp.	1999	—
+2	K022995	Collatek Hydrogel	Biocore Medical Technologies, Inc.	2002	—
+2	K040019	Silverseal	Noble Fiber Technologies	2004	—
+3	K063069	Silvaklenz Skin and Wound Clenser Solution	Medical Molecular Therapuetics, LLC	2007	—
+4	K073547	Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…	Anacapa Technologies, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	1	0
2004	1	0
2006	1	0
2007	3	0
2008	4	0
2009	7	0
2010	4	0
2011	2	0
2012	2	0
2013	3	0
2014	6	0
2015	7	0
2016	5	0
2017	9	0
2018	6	0
2019	4	0
2020	6	0
2021	1	0
2022	7	0
2023	7	0
2024	8	0
2025	5	0
2026	13	0

FIG. 1 — Lineage of K894541, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (115)

See all 115

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

Number	Device	Applicant	Decided	Descendants
K991202	Modification to Woun'dres	Coloplast Corp.	1999	112
K990440	Gentell Hydrogel Spray Gel, Appligard Squeeze	Gentell	1999	0
K983042	Sween Woun'dres	Coloplast Corp.	1998	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?

Of its descendants, K991202 (Coloplast Corp., 1999) has gone furthest, with 112 descendants of its own.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K894541 · printed Nov 6, 2026

Cite this page

510(k) Report. “K894541: Carrington 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/K894541

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026