# K022854: Acell Ubm Hydrated Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acell, Inc.
- Decided: Dec 30, 2002 after 137 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K881854 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K943781: Acryderm Advanced Wound Dressing, Acrymed, Inc. (1994) Summary page 1.

## Indications for use
The ACell UBM Hydrated Wound Dressing is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K022854
Methodology: https://510kreport.com/methodology