Cleared Traditional

K945330 - ALLEVYN ADHESIVE

K945330 is the FDA 510(k) clearance for ALLEVYN ADHESIVE 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 100-day FDA review.

K945330 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Feb 1995
Decision
100d
Days
Class 1
Risk

K945330 is an FDA 510(k) clearance for the ALLEVYN ADHESIVE. 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 9, 1995 after a review of 100 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 K945330 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 01, 1994
Decision Date February 09, 1995
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K945330.
WOUNDFOAM 4 X 4
K953070 · Trinity Laboratories, Inc. · Sep 1995
CUTINOVA CAVITY
K952526 · Beiersdorf, Inc. · Aug 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1995
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS
K946269 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1995
CUTINOVA THIN WOUND DRESSING
K944581 · Beiersdorf, Inc. · Dec 1994
KERLIX ZINC SALINE DRESSING
K944468 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994