# K961323: Lyofoam Extra C Odor Absorbing Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acme United Corp.
- Decided: Jun 19, 1996 after 75 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 K864084 (1986). 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)
- K864084: Lyofoam C Odor-Absorbing Dressing, Acme United Corp. (1986) Summary page 3.
- K952565: Lyofoam Extra, Acme United Corp. (1995) Summary page 2.

## Indications for use
The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds

Source page: https://510kreport.com/device/K961323
Methodology: https://510kreport.com/methodology