# K972329: Osmocyte RA Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Dec 10, 1997 after 170 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) Elastogel™ Island Dressing: named in the summary without a submission number
- (no number) Vigilon® Primary Wound Dressing: named in the summary without a submission number
- (no number) PolyMem® Adhesive Urethane Dressing: named in the summary without a submission number

## Indications for use
Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, Cuts and abrasions.

Source page: https://510kreport.com/device/K972329
Methodology: https://510kreport.com/methodology