# K860085: Lyofoam Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Acme United Corp.
- Decided: Jun 27, 1986 after 169 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963293: Augustine Medical Wound Care System Model 68XXX (1997), 1 descendant of its own
- K020077: Modification to Augustine Medical Wound Care System, Model 68XXX (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K860085
Methodology: https://510kreport.com/methodology