510(k) Report

510(k) · Cleared

Cleared

Comfeel:Alginate Dressing

K953497510(k) TraditionalCleared Sep 29, 199565-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

Coloplast A/S · KMF Bandage, Liquid

Cleared on Sep 29, 1995 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Sep 29, 1995
Review
65 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2011: 2 descendants cleared1995200020052010201520202025
  1. This deviceK953497 Comfeel:Alginate DressingColoplast A/S · 1995
  2. Descendant · cites it directly · 2 of its ownK983519 Comfeel Seasorb DressingColoplast Corp. · 1998 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK102942 Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd. · 2011
  4. Descendant · 2 generations on · 0 of its ownK102943 Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K983519Comfeel Seasorb DressingColoplast Corp. · 1998 · cites it directly2descendants
  • K102942Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd. · 2011 · 2 generations on0descendants
  • K102943Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953497Comfeel:Alginate DressingColoplast A/S1995—
+1K983519Comfeel Seasorb DressingColoplast Corp.19981
+2K102942Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd.2011—
+2K102943Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201120
FIG. 1 — Lineage of K953497, 1995–2011Source: 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), 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K983519Comfeel Seasorb DressingColoplast Corp.19982

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, K983519 (Coloplast Corp., 1998) has gone furthest, with 2 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 Coloplast A/S

71 FDA decisions under this applicant name. See the company

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018

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/K953497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953497: Comfeel:Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953497

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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