Cleared Traditional

K925376 - COMFEEL(R) WOUND DRESSING SD

K925376 is an FDA 510(k) clearance for COMFEEL WOUND DRESSING SD, manufactured by Coloplast A/S. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K925376 · Coloplast A/S · General & Plastic Surgery device
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Mar 1993
Decision
144d
Days
Class 1
Risk

K925376 is an FDA 510(k) clearance for the COMFEEL(R) WOUND DRESSING SD. 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 March 16, 1993 after a review of 144 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

FDA 510(k) Submission Details - K925376

510(k) Number K925376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1992
Decision Date March 16, 1993
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
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 92
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K925376.
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
K930468 · 3M Health Care, Ltd. · Aug 1993
3M TEGASORB THIN HYDROCOLLOID DRESSING
K924280 · 3M Health Care, Ltd. · May 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
CURITY CALCIUM ALGINATE WOUND DRESSING
K925001 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
ATRAUM WOUND DRESSING--MODIFICATION
K922760 · Axiom Medical, Inc. · Oct 1992
COMFEEL WOUND DRESSING ORD
K922461 · Coloplast A/S · Aug 1992