Cleared Traditional

K920925 - COMFEEL CONTOUR DRESSING

K920925 is the FDA 510(k) clearance for COMFEEL CONTOUR DRESSING by Coloplast A/S. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920925 · Coloplast A/S · General & Plastic Surgery device
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May 1992
Decision
90d
Days
Class 1
Risk

K920925 is an FDA 510(k) clearance for the COMFEEL CONTOUR DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast A/S devices

Submission Details

510(k) Number K920925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date May 28, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 33
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K920925.
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979