510(k) · Cleared

Cleared

Silver PU Antibacterial Foam Dressing - Non Adherent and Island

K091013510(k) TraditionalCleared Jul 30, 2009112-day reviewClass U

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

Advanced Medical Solutions Limited · FRO Dressing, Wound, Drug

Cleared on Jul 30, 2009 as substantially equivalent to K063835 (Smith & Nephew, Inc., 2007) and 2 other predicates after a 112-day review. Its family tree reaches back 3 generations to 2000.

Decided: Jul 30, 2009
Review: 112 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K000051 (2000). 6 ancestors in all, the oldest K963096 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK000051 Acticoat Foam DressingWestaim Biomedical, Inc. · 2000 · Recalled
2 generations backK050030 Acticoat Moisture Control DressingSmith & Nephew, Inc. · 2005
1 generation backK063835 Allevyn AG DressingSmith & Nephew, Inc. · 2007
This deviceK091013 Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000051	Acticoat Foam Dressing	Westaim Biomedical, Inc.	2000	1
−2	K050030	Acticoat Moisture Control Dressing	Smith & Nephew, Inc.	2005	—
−1	K063835	Allevyn AG Dressing	Smith & Nephew, Inc.	2007	—
0 (this device)	K091013	Silver PU Antibacterial Foam Dressing - Non Adherent and Island	Advanced Medical Solutions Limited	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2007	2	0

FIG. 1 — Lineage of K091013, 2000–2009Source: 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

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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
*	K063835	Allevyn AG Dressing Summary page 1 …- Unclassified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- Allevyn Ag Dressings, 510(k) #K063 835, manufactured by Smith & Nephew. Mepilex Ag Dressing, 510(k) #K07 1354 / K06 1554, manufactured by M6lnlycke Health Care. Device…	Smith & Nephew, Inc.	2007	—
*	K071354	Mepilex AG Dressing Summary page 1 …Legally marketed device(s) for substantial equivalence comparison:- Allevyn Ag Dressings, 510(k) #K063 835, manufactured by Smith & Nephew. Mepilex Ag Dressing, 510(k) #K07 1354 / K06 1554, manufactured by M6lnlycke Health Care. Device Description:- The Silver PU Antibacterial Foam Dressings is available…	Monlycke Health Care	2007	—
*	K061554	Mepilex AG Absorbent Silicone-Coated Dressing Summary page 1 …rketed device(s) for substantial equivalence comparison:- Allevyn Ag Dressings, 510(k) #K063 835, manufactured by Smith & Nephew. Mepilex Ag Dressing, 510(k) #K07 1354 / K06 1554, manufactured by M6lnlycke Health Care. Device Description:- The Silver PU Antibacterial Foam Dressings is available in two vari…	Molnlycke Health Care	2007	—

Also cleared against K063835: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
1 of the 6 ancestors has a recall of any class.
1 other device also cites its predicate K063835.

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?

Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as:

Decubitus (pressure) ulcers

Diabetic ulcers

Leg ulcers

Graft and donor sites

Lacerations and abrasions

1st and 2nd degree burns

Trauma wounds (derreal lesions, trauma injuries or incisions)

Post-operative surgical wounds

The Silver PU Antibacterial Foam Dressings are indicated for external use only

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091013 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091013: Silver PU Antibacterial Foam Dressing - Non Adherent and Island.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091013

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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