510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961452Substantially Equivalent

Lyofoam Extra 'a' Sterile Adhesive Wound Dressing

Acme United Corp., Fairfield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961452 is the FDA 510(k) clearance record for LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING, a class I device, cleared for Acme United Corp. on under FDA product code KMF (Bandage, Liquid). FDA records list 27 510(k) clearances for Acme United Corp., from to . As of , FDA records show no recalls naming K961452.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Acme United Corp. 75 Kings Hwy. Cut-Off, Fairfield CT
510(k) summary
Summary
Third party review
No

Clearances, product code KMF

Trailing 12 months

FDA records hold no clearances under product code KMF in the trailing twelve months.

FDA records show no clearances under product code KMF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260