Cleared Traditional

K963096 - ALLEVYN HYDRO POLY DRESSING ND ALL TRAC...

K963096 is the FDA 510(k) clearance for ALLEVYN HYDRO POLY DRESSING ND ALL TRAC... 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 77-day FDA review.

K963096 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Oct 1996
Decision
77d
Days
Class 1
Risk

K963096 is an FDA 510(k) clearance for the ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING. 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 October 25, 1996 after a review of 77 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 Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K963096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date October 25, 1996
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 K963096.
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · Johnson & Johnson Medical, Inc. · Dec 1996
COMFEEL:ALGINATE FILLER
K954857 · Coloplast 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