Cleared Traditional

K961323 - LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING

K961323 is an FDA 510(k) clearance for LYOFOAM EXTRA C ODOR ABSORBING WOUND DR..., 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 75-day FDA review.

K961323 · Acme United Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
75d
Days
Class 1
Risk

K961323 is an FDA 510(k) clearance for the LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING. 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 June 19, 1996 after a review of 75 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 Acme United Corp. devices

FDA 510(k) Submission Details - K961323

510(k) Number K961323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date June 19, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 K961323.
PROD NO. 01-1694 - 4X4 FOAM DRESSING
K954728 · Continental Medical Laboratories, Inc. · Sep 1996
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
K962740 · Medi-Flex Hospital Products, Inc. · Sep 1996
SORBCEL ALGINATE/CMC WOUND DRESSING
K962421 · Innovative Technologies , Ltd. · Jul 1996
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
K961662 · Mariner Biomedical, Inc. · Jun 1996
ACTICOAT SILVER COATED DRESSING
K955453 · Westaim Technologies, Inc. · May 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K961452 · Acme United Corp. · May 1996