Cleared Traditional

K901877 - ALLEVYN DRESSING (LABELING REVISED)

K901877 is an FDA 510(k) clearance for ALLEVYN DRESSING (LABELING REVISED), 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 57-day FDA review.

K901877 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
57d
Days
Class 1
Risk

K901877 is an FDA 510(k) clearance for the ALLEVYN DRESSING (LABELING REVISED). 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 June 22, 1990 after a review of 57 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

FDA 510(k) Submission Details - K901877

510(k) Number K901877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date June 22, 1990
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 147
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K901877.
FORTEX(TM) WOUND DRESSING
K914314 · Calgon Vestal Div. · Oct 1991
INTRASITE GEL (LABELING REVISION)
K904411 · Smith & Nephew United, Inc. · Nov 1990
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · Acme United Corp. · Sep 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
K900127 · Ferris Mfg. Corp. · May 1990
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990