Cleared Traditional

K952565 - LYOFOAM EXTRA

K952565 is an FDA 510(k) clearance for LYOFOAM EXTRA, manufactured by Acme United Corp.. The device is a Class 1 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K952565

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
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 151
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K952565.
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
K955399 · Lange Medical Products, Inc. · Feb 1996
3M NO STING BARRIER FILM
K955103 · 3M Medical Products Group · Feb 1996
HEMO-BARRIER
K953500 · Asia Dynamics, Inc. · Jan 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