510(k) · Cleared

Cleared

Mepilex AG Dressing

K071354510(k) TraditionalCleared Jul 13, 200759-day reviewClass U

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

Monlycke Health Care · FRO Dressing, Wound, Drug

Cleared on Jul 13, 2007 as substantially equivalent to K061554 (Molnlycke Health Care, 2007) after a 59-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.

Decided: Jul 13, 2007
Review: 59 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061554 (2007). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK061554 Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 2007
This deviceK071354 Mepilex AG DressingMonlycke Health Care · 2007
Descendant · cites it directly · 0 of its ownK091013 Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009

Most influential descendants

Showing 1 of 1 · See all

K091013Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061554	Mepilex AG Absorbent Silicone-Coated Dressing	Molnlycke Health Care	2007	—
0 (this device)	K071354	Mepilex AG Dressing	Monlycke Health Care	2007	—
+1	K091013	Silver PU Antibacterial Foam Dressing - Non Adherent and Island	Advanced Medical Solutions Limited	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K071354, 2007–2009Source: 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? (1)

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
*	K061554	Mepilex AG Absorbent Silicone-Coated Dressing Summary page 1 …des that Mepilex Ag Absorbent Silicone-Coated Dressing is substantially equivalent to the currently marketed Mepilex Ag Absorbent Silicone-Coated Dressing marketed under K061 554. Special 510(k) Mdtnlycke Health Care DEPART…	Molnlycke Health Care	2007	—

Also cleared against K061554: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K091013	Silver PU Antibacterial Foam Dressing - Non Adherent and Island	Advanced Medical Solutions Limited	2009	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?

Its one ancestor has no recall.
Of its descendants, K091013 (Advanced Medical Solutions Limited, 2009) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K061554.

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?

Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071354 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071354: Mepilex AG Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071354

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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