# K955863: Alldress Multi Layered Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke/Scott Health Care
- Decided: Mar 13, 1996 after 77 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
Longest line of descent: 1 generation back to K941263 (1994). 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)
- K945206: Alldress Multi Layered Wound Dressing, Scott Health Care (1995) Summary page 1.
- K941263: Comfeel Plus Wound Dressing, Richard Hamer Assoc., Inc. (1994) Summary page 1.

## Indications for use
For the dressing and management of chronic/open wounds.

Source page: https://510kreport.com/device/K955863
Methodology: https://510kreport.com/methodology