# K961452: Lyofoam Extra 'A' Sterile Adhesive Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acme United Corp.
- Decided: May 31, 1996 after 45 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895764 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895764: Modified Lyofoam Wound Dressings, Acme United Corp. (1990) Summary page 3.
- K952565: Lyofoam Extra, Acme United Corp. (1995) Summary page 3.

## Indications for use
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds

Source page: https://510kreport.com/device/K961452
Methodology: https://510kreport.com/methodology