510(k) · Cleared

Cleared

Acryderm Silver Antimicrobial Otc Wound Gel

K070333510(k) TraditionalCleared Jul 10, 2007155-day reviewClass U

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

Acrymed, Inc. · FRO Dressing, Wound, Drug

Cleared on Jul 10, 2007 as substantially equivalent to K011994 (Acrymed, Inc., 2001) after a 155-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.

Decided: Jul 10, 2007
Review: 155 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011994 (2001). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK011994 Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 2001
This deviceK070333 Acryderm Silver Antimicrobial Otc Wound GelAcrymed, Inc. · 2007
Descendant · cites it directly · 6 of its ownK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
Descendant · 2 generations on · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
Descendant · cites it directly · 2 of its ownK073197 Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited · 2008
Descendant · 2 generations on · 1 of its ownK140483 Asap Otc Wound Dressing GelAbl Medical, LLC · 2014
Descendant · 2 generations on · 1 of its ownK131176 Ross RU Skin DiscontinuitiesBiotd S.A. · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all

K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly6descendants
K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · 2 generations on2descendants
K073197Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited · 2008 · cites it directly2descendants
K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 2014 · 2 generations on1descendant
K131176Ross RU Skin DiscontinuitiesBiotd S.A. · 2014 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011994	Acryderm Silver Anttimicrobial Wound Gel Model# a-002101	Acrymed, Inc.	2001	—
0 (this device)	K070333	Acryderm Silver Antimicrobial Otc Wound Gel	Acrymed, Inc.	2007	—
+1	K082333	Asap Wound Dressing Gel	American Biotech Labs	2009	—
+2	K092826	Asap Antimicrobial Silver Wound Dressing Gel	American Biotech Labs	2009	—
+1	K073197	Silver Antimicrobial Wound Gel	Advanced Medical Solutions Limited	2008	—
+2	K140483	Asap Otc Wound Dressing Gel	Abl Medical, LLC	2014	—
+2	K131176	Ross RU Skin Discontinuities	Biotd S.A.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	2	0
2011	1	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2024	1	0

FIG. 1 — Lineage of K070333, 2001–2024Source: 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? (3)

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
*	K011994	Acryderm Silver Anttimicrobial Wound Gel Model# a-002101	Acrymed, Inc.	2001	—
*	—	SilverMed Antimicrobial Silver Hydrogel Named without a submission number			—
*	—	Silver Shield Antimicrobial Skin and Wound Gel Named without a submission number			—

Also cleared against K011994: 11 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K082333	Asap Wound Dressing Gel	American Biotech Labs	2009	6
K073197	Silver Antimicrobial Wound Gel	Advanced Medical Solutions Limited	2008	2

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?

Its one ancestor has no recall.
Of its descendants, K082333 (American Biotech Labs, 2009) has gone furthest, with 6 descendants of its own.
11 other devices also cite its predicate K011994.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, bums, scrapes and minor surgical procedures wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070333: Acryderm Silver Antimicrobial Otc 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/K070333

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