# K971612: Osmo/Pca Pillow Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Mar 16, 1998 after 318 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OsmoCyte™ Pillow Wound Dressing: named in the summary without a submission number
- (no number) lamin® Hydrating Gel: named in the summary without a submission number

## Indications for use
Exudating wounds, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, trauma injuries or incisions.

Source page: https://510kreport.com/device/K971612
Methodology: https://510kreport.com/methodology