510(k) · Cleared

Cleared

Mepitel Non Adherent Silicone Dressing

K984371510(k) TraditionalCleared Mar 3, 199986-day reviewClass U

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

Molnlycke Health Care, Inc. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Mar 3, 1999 as substantially equivalent to K914604 (Molnlycke Clinical Products AB, 1992) after an 86-day review. Its family tree reaches back 1 generation to 1992. 81 later devices descend from it.

Decided: Mar 3, 1999
Review: 86 days
Class: Class U
Product code: MGP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914604 (1992). 81 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
This deviceK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
Descendant · cites it directly · 59 of its ownK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
Descendant · 2 generations on · 54 of its ownK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
Descendant · cites it directly · 14 of its ownK141847 Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015
Descendant · 3 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
Descendant · 3 generations on · 13 of its ownK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2007high 12 (2024) · low 1 (2007)2026

Most influential descendants

Showing 5 of 81 · See all

K063271Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007 · cites it directly59descendants
K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008 · 2 generations on54descendants
K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015 · cites it directly14descendants
K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 3 generations on13descendants
K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc. · 2012 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914604	Mepitel Non-Adherent Silicone Dressing	Molnlycke Clinical Products AB	1992	—
0 (this device)	K984371	Mepitel Non Adherent Silicone Dressing	Molnlycke Health Care, Inc.	1999	—
+1	K063271	Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…	Convatec, A Division of E.R. Squibb & Sons, LLC	2007	—
+2	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—
+1	K141847	Avance Foam Dressing Kits	Molnlycke Health Care Us, LLC	2015	—
+3	K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	2014	—
+3	K121275	Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber	Convatec, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	3	0
2010	2	0
2011	3	0
2012	2	0
2013	4	0
2014	5	0
2015	5	0
2016	7	0
2017	3	0
2018	8	0
2019	6	0
2020	2	0
2021	1	0
2022	7	0
2023	7	0
2024	12	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K984371, 1992–2026Source: 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 MGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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
*	K914604	Mepitel Non-Adherent Silicone Dressing Summary page 1 …tion and intended use to the Mélnlycke Health Care’s own Mepitel® Non Adherent Silicone Dressing placed in commercial distribution pursuant to 510(k) notification number K914604. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cmx 7.5 cm); 3" x 4".(7.5…	Molnlycke Clinical Products AB	1992	—

What descends from it? (81)

See all 81

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

Number	Device	Applicant	Decided	Descendants
K063271	Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…	Convatec, A Division of E.R. Squibb & Sons, LLC	2007	59
K141847	Avance Foam Dressing Kits	Molnlycke Health Care Us, LLC	2015	14
K123961	Sentrex Biosponge MPD	Bionova Medical, Inc.	2013	4
K130040	Mepitel AG	Molnlycke Health Care	2014	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, K063271 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2007) has gone furthest, with 59 descendants of its own.

How does its category compare?

All MGP devices

MGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

Too few MGP 510(k)s in any year since 2007 to give a median.

Recalls per year · MGP

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGP

8in 2024

2007high 52 (2021) · low 0 (2008)2025

MAUDE reports naming product code MGP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	1
2010	—	0	2
2011	—	1	4
2012	—	0	0
2013	—	0	7
2014	—	0	1
2015	—	0	3
2016	—	0	1
2017	—	0	6
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	52
2022	—	0	3
2023	—	0	3
2024	—	0	8
2025	—	0	0
2026	—	0	—

What is it indicated for?

Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984371 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984371: Mepitel Non Adherent Silicone Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984371

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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