Cleared Traditional

K954857 - COMFEEL:ALGINATE FILLER

K954857 is an FDA 510(k) clearance for COMFEEL:ALGINATE FILLER, manufactured by Coloplast Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K954857 · Coloplast Corp. · General & Plastic Surgery device
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Nov 1995
Decision
22d
Days
Class 1
Risk

K954857 is an FDA 510(k) clearance for the COMFEEL:ALGINATE FILLER. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Coloplast Corp. (Fort Worth, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 22 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 Corp. devices

FDA 510(k) Submission Details - K954857

510(k) Number K954857 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 23, 1995
Decision Date November 14, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 145
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K954857.
3M NO STING BARRIER FILM
K955103 · 3M Medical Products Group · Feb 1996
HEMO-BARRIER
K953500 · Asia Dynamics, Inc. · Jan 1996
LYOFOAM EXTRA
K952565 · Acme United Corp. · Nov 1995
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
K953403 · Deroyal Industries, Inc. · Oct 1995
COMFEEL:ALGINATE DRESSING
K953497 · Coloplast A/S · Sep 1995
HYDROPHILIC FOAM DRESSING
K953019 · Busse Hospital Disposables, Inc. · Sep 1995