Cleared Traditional

K914147 - ALLEVLYN WOUND DRESSING

K914147 is the FDA 510(k) clearance for ALLEVLYN WOUND DRESSING by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Smith & Nephew United, Inc. devices

Submission Details

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.

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 68
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K914147.
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992
BRND SKIN PROTECTION PREP SERIES 33XX
K920794 · 3M Health Care, Ltd. · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
INTRASITE GEL (LABELING REVISION)
K904411 · Smith & Nephew United, Inc. · Nov 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990