Cleared Traditional

K914147 - ALLEVLYN WOUND DRESSING, MODIFICATION

K914147 is an FDA 510(k) clearance for ALLEVLYN WOUND DRESSING, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K914147 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Feb 1992
Decision
140d
Days
Class 1
Risk

K914147 is an FDA 510(k) clearance for the ALLEVLYN WOUND DRESSING, MODIFICATION. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on February 3, 1992 after a review of 140 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.

FDA 510(k) Submission Details - K914147

510(k) Number K914147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date February 03, 1992
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K914147.
ULCUFLEX HYDROCULLOID DRESSING
K920367 · Industrias Palex C/O Dma Med-Chem Corp. · Mar 1992
ULCUFLEX HYDROCOLLOID PASTE
K920368 · Industrias Palex C/O Dma Med-Chem Corp. · Mar 1992
CRITIC-AID WOUND DRESSING
K912506 · Sween Corp. · Mar 1992
FORTEX(TM) WOUND DRESSING
K914314 · Calgon Vestal Div. · Oct 1991
SPENCIO SKIN GUARD KIT
K910927 · Spenco Medical Corp. · Jun 1991
HYPERGEL PROTECTIVE WOUND GEL
K905439 · Scott Health Care · May 1991
K914147 · ALLEVLYN WOUND DRESSING, MODIFICATION
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