510(k) Report

510(k) · Cleared

Cleared

Hydrocolloid Wound Dressing

K943258510(k) TraditionalCleared Aug 4, 199429-day reviewClass I21 CFR 880.5090

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

Convatec, A Division of E.R. Squibb & Sons · KMF Bandage, Liquid

Cleared on Aug 4, 1994 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 55 later devices descend from it.

Decided
Aug 4, 1994
Review
29 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2009: 2 descendants cleared2011: 3 descendants cleared2019: 3 descendants cleared2013: 3 descendants cleared2014: 4 descendants cleared2015: 2 descendants cleared2017: 1 descendant cleared2022: 4 descendants cleared2012: 2 descendants cleared2016: 4 descendants cleared2010: 2 descendants cleared2018: 6 descendants cleared2024: 10 descendants cleared2023: 4 descendants cleared2021: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK943258 Hydrocolloid Wound DressingConvatec, A Division of E.R. Squibb & Sons · 1994
  2. Descendant · cites it directly · 54 of its ownK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
  3. Descendant · 2 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
  4. Descendant · 2 generations on · 13 of its ownK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
  5. Descendant · 3 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
  6. Descendant · 2 generations on · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 22011: 32012: 22013: 32014: 42015: 22016: 42017: 12018: 62019: 32020: 22021: 12022: 42023: 42024: 102025: 1
2008high 10 (2024) · low 0 (2026)2026

Most influential descendants

Showing 5 of 55 · See all
  • K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008 · cites it directly54descendants
  • K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 2 generations on13descendants
  • K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc. · 2012 · 2 generations on13descendants
  • K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 3 generations on5descendants
  • K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943258Hydrocolloid Wound DressingConvatec, A Division of E.R. Squibb & Sons1994—
+1K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC2008—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC2014—
+2K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc.2012—
+3K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical2014—
+2K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201020
201130
201220
201330
201440
201520
201640
201710
201860
201930
202020
202110
202240
202340
2024100
202510
FIG. 1 — Lineage of K943258, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KMF? 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 KMF device

  1. #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC200854

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, K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) has gone furthest, with 54 descendants of its own.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMF

1in 2024

2007: 22008: 32009: 32010: 12012: 12014: 22016: 22018: 12019: 12024: 1
2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2008: 35 days median2009: 213 days median
2007high 213 (2009) · low 35 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KMF

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KMF

12in 2025

2007: 62008: 22009: 62010: 72011: 162012: 32013: 342014: 242015: 132016: 182017: 162018: 102019: 62020: 82021: 102022: 72023: 62024: 62025: 12
2007high 34 (2013) · low 2 (2008)2025

MAUDE reports naming product code KMF, 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
20072—16
200833502
2009321306
20101—07
20110—116
20121—03
20130—034
20142—024
20150—013
20162—018
20170—016
20181—010
20191—06
20200—08
20210—010
20220—07
20230—06
20241—06
20250—012
20260—0—

More from Convatec, A Division of E.R. Squibb &…

81 FDA decisions under this applicant name. See the company

  • K013814Absorbent Antimicrobial Wound DressingConvatec, A Division of E.R. Squibb & Sons · 2002
  • K990964Signadress Duoderm DressingConvatec, A Division of E.R. Squibb & Sons · 1999
  • K984388HA Absorbent Wound DressingConvatec, A Division of E.R. Squibb & Sons · 1999
  • K980720Nonwoven PadConvatec, A Division of E.R. Squibb & Sons · 1998
  • K980382Non-Woven CompressConvatec, A Division of E.R. Squibb & Sons · 1998

Recent decisions in KMF

The KMF category page

  • K241916TearRepair Liquid Skin ProtectantOptmed, Inc. · 2024
  • K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
  • K171148Aleo BME Liquid BandageAleo Bme, Inc. · 2018
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
  • K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC · 2016

https://510kreport.com/device/K943258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943258: Hydrocolloid 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/K943258

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026