510(k) · Cleared

Cleared

Silver Foam Wound Dressing

K914579510(k) TraditionalCleared Feb 21, 1992128-day reviewClass U

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

Vitaphore Corp. · FRO Dressing, Wound, Drug

Cleared on Feb 21, 1992 after a 128-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 162 later devices descend from it.

Decided: Feb 21, 1992
Review: 128 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

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

This deviceK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
Descendant · cites it directly · 161 of its ownK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
Descendant · 2 generations on · 149 of its ownK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
Descendant · 3 generations on · 102 of its ownK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
Descendant · 4 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
Descendant · 5 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008

Showing 5 of 162 descendants. See all descendants

Descendants cleared per year

1996high 12 (2014) · low 0 (1997)2026

Most influential descendants

Showing 5 of 162 · See all

K955453Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996 · cites it directly161descendants
K981299Silverlon Contact Wound DressingArgentum International, LLC · 1998 · 2 generations on149descendants
K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003 · 3 generations on102descendants
K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 4 generations on73descendants
K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 5 generations on66descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914579	Silver Foam Wound Dressing	Vitaphore Corp.	1992	—
+1	K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	1996	—
+2	K981299	Silverlon Contact Wound Dressing	Argentum International, LLC	1998	—
+3	K023612	Silverlon Contact Wound Dressing	Argentum International, LLC	2003	—
+4	K063069	Silvaklenz Skin and Wound Clenser Solution	Medical Molecular Therapuetics, LLC	2007	—
+5	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
1996	1	0
1998	2	0
1999	2	0
2000	1	0
2001	1	0
2003	2	0
2004	5	0
2005	4	0
2006	3	0
2007	7	0
2008	4	0
2009	11	0
2010	7	0
2011	4	0
2012	3	0
2013	6	0
2014	12	0
2015	9	0
2016	10	0
2017	7	0
2018	7	0
2019	5	0
2020	4	0
2021	3	0
2022	7	0
2023	8	0
2024	11	0
2025	4	0
2026	12	0

FIG. 1 — Lineage of K914579, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (162)

See all 162

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

Number	Device	Applicant	Decided	Descendants
K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	1996	161

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, K955453 (Westaim Technologies, Inc., 1996) has gone furthest, with 161 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/K914579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914579: Silver Foam Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914579

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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