Cleared Traditional

K953497 - COMFEEL:ALGINATE DRESSING

K953497 is the FDA 510(k) clearance for COMFEEL:ALGINATE 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 65-day FDA review.

K953497 · Coloplast A/S · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
65d
Days
Class 1
Risk

K953497 is an FDA 510(k) clearance for the COMFEEL:ALGINATE DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Coloplast A/S (Fort Worth, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast A/S devices

Submission Details

510(k) Number K953497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date September 29, 1995
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
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 K953497.
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
K953403 · Deroyal Industries, Inc. · Oct 1995
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994