Cleared Traditional

LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (K961323) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 15
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K961323.
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979