Cleared Traditional

K952565 - LYOFOAM EXTRA

K952565 is the FDA 510(k) clearance for LYOFOAM EXTRA by Acme United Corp.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K952565 · Acme United Corp. · General & Plastic Surgery device
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Nov 1995
Decision
165d
Days
Class 1
Risk

K952565 is an FDA 510(k) clearance for the LYOFOAM EXTRA. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Acme United Corp. (Fairfield, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 165 days - an extended review 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: 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 Acme United Corp. devices

Submission Details

510(k) Number K952565 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 02, 1995
Decision Date November 14, 1995
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
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 69
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K952565.
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
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc. · Oct 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