Cleared Traditional

K894916 - COMFEEL TRANSPARENT DRESSING

K894916 is an FDA 510(k) clearance for COMFEEL TRANSPARENT DRESSING, manufactured by Coloplast A/S. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K894916 · Coloplast A/S · General & Plastic Surgery device
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Sep 1989
Decision
55d
Days
Class 1
Risk

K894916 is an FDA 510(k) clearance for the COMFEEL TRANSPARENT DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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

FDA 510(k) Submission Details - K894916

510(k) Number K894916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date September 26, 1989
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 86
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K894916.
LEUKOSPORT(TM) ADHESIVE TAPE
K894367 · Beiersdorf, Inc. · Nov 1989
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
OPSITE I.V. 3000
K895353 · Smith & Nephew United, Inc. · Sep 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · Convatec, A Division of E.R. Squibb & Sons · Sep 1989
PRIMAPORE I.V.
K893900 · Smith & Nephew United, Inc. · Aug 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989