510(k) · Cleared

Cleared

Modification to Acticoat Foam Dressing

K010447510(k) SpecialCleared Mar 15, 200130-day reviewClass U

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

Westaim Biomedical, Inc. · FRO Dressing, Wound, Drug

Cleared on Mar 15, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.

Decided: Mar 15, 2001
Review: 30 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

33 later devices descend from it, 1 citing it directly.

This deviceK010447 Modification to Acticoat Foam DressingWestaim Biomedical, Inc. · 2001
Descendant · cites it directly · 32 of its ownK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
Descendant · 2 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
Descendant · 2 generations on · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
Descendant · 3 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003high 5 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 33 · See all

K022416Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003 · cites it directly32descendants
K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 2 generations on17descendants
K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · 2 generations on6descendants
K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010447	Modification to Acticoat Foam Dressing	Westaim Biomedical, Inc.	2001	—
+1	K022416	Contreet Foam Adhesive/Non-Adhesive	Coloplast Corp.	2003	—
+2	K033869	Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)	Coloplast Corp.	2004	—
+2	K100218	Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM	Coloplast A/S	2010	—
+2	K062559	Urgocell AG Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2007	—
+3	K140954	Luofucon Silver PU Antibacterial Foam Dressing	Huizhou Foryou Medical Devices Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	3	0
2007	3	0
2009	1	0
2010	4	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	2	0
2022	1	0
2023	3	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K010447, 2001–2026Source: 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? (33)

See all 33

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022416	Contreet Foam Adhesive/Non-Adhesive	Coloplast Corp.	2003	32

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, K022416 (Coloplast Corp., 2003) has gone furthest, with 32 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/K010447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010447: Modification to Acticoat Foam Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010447

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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