510(k) Report

510(k) · Cleared

Cleared

Mepitel Non-Adherent Silicone Dressing

K914604510(k) TraditionalCleared Mar 25, 1992160-day reviewClass I21 CFR 878.4014

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

Molnlycke Clinical Products AB · NAB Gauze / Sponge,Nonresorbable For External Use

Cleared on Mar 25, 1992 after a 160-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 82 later devices descend from it.

Decided
Mar 25, 1992
Review
160 days
Class
Class I
Product code
NAB
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2015: 5 descendants cleared2014: 5 descendants cleared2007: 1 descendant cleared2013: 4 descendants cleared2008: 1 descendant cleared2009: 3 descendants cleared2022: 7 descendants cleared2016: 7 descendants cleared2017: 3 descendants cleared2011: 3 descendants cleared2019: 6 descendants cleared2012: 2 descendants cleared2010: 2 descendants cleared2023: 7 descendants cleared2018: 8 descendants cleared2024: 12 descendants cleared2026: 1 descendant cleared2021: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
  2. Descendant · cites it directly · 81 of its ownK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
  3. Descendant · 2 generations on · 59 of its ownK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
  4. Descendant · 3 generations on · 54 of its ownK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
  5. Descendant · 2 generations on · 14 of its ownK141847 Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015
  6. Descendant · 4 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014

Showing 5 of 82 descendants. See all descendants

Descendants cleared per year

1999: 12007: 12008: 12009: 32010: 22011: 32012: 22013: 42014: 52015: 52016: 72017: 32018: 82019: 62020: 22021: 12022: 72023: 72024: 122025: 12026: 1
1999high 12 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 82 · See all
  • K984371Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999 · cites it directly81descendants
  • K063271Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007 · 2 generations on59descendants
  • K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008 · 3 generations on54descendants
  • K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015 · 2 generations on14descendants
  • K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914604Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB1992—
+1K984371Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc.1999—
+2K063271Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Convatec, A Division of E.R. Squibb & Sons, LLC2007—
+3K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC2008—
+2K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC2015—
+4K122817Silverlon Island Wound DressingArgentum Medical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200710
200810
200930
201020
201130
201220
201340
201450
201550
201670
201730
201880
201960
202020
202110
202270
202370
2024120
202510
202610
FIG. 1 — Lineage of K914604, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NAB? 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?

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

What descends from it? (82)

See all 82

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

NumberDeviceApplicantDecidedDescendants
K984371Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc.199981

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, K984371 (Molnlycke Health Care, Inc., 1999) has gone furthest, with 81 descendants of its own.

How does its category compare?

All NAB devices

NAB Gauze / Sponge,Nonresorbable For External Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NAB

FDA has decided no NAB device since 2007.

Median 510(k) review, days · NAB

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

Recalls per year · NAB

1in 2020

2018: 22020: 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · NAB

12in 2025

2007: 12008: 62009: 42010: 42011: 12012: 82013: 42014: 42015: 102016: 252017: 242018: 222019: 232020: 112021: 112022: 122023: 152024: 62025: 12
2007high 25 (2016) · low 1 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—06
20090—04
20100—04
20110—01
20120—08
20130—04
20140—04
20150—010
20160—025
20170—024
20180—222
20190—023
20200—111
20210—011
20220—012
20230—015
20240—06
20250—012
20260—0—

Recent decisions in NAB

The NAB category page

  • K946015Ivalon External SpongeIvalon · 1995
  • K940755Isolyer (4X4, 8PLY)Isolyer Co. · 1994
  • K931610Omnisorb II, Nonwoven Sponge, Sterile and NonOmni Mfg., Inc. · 1993
  • K925590Multi-Trauma DressingGam Industries, Inc. · 1993
  • K926072K-Band and K-CrepeParema, Ltd. · 1993

https://510kreport.com/device/K914604 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914604: Mepitel Non-Adherent Silicone Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914604

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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