# K962623: Osmocyte Ultra/PE Pillow Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Nov 26, 1996 after 144 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) HyQ Wound Dressing (Kingston Technologies): named in the summary without a submission number
- (no number) Allevyn Cavity Dressing (Smith + Nephew): named in the summary without a submission number
- (no number) Kaltostat Wound Packing (Calgon Vestal): named in the summary without a submission number
- (no number) Aquacel (Convatec): named in the summary without a submission number
- (no number) Sorbsan Topical Wound Dressing (Dow Hickam): named in the summary without a submission number

## Indications for use
An absorptive pillow dressing for the management of exudating wounds, infected and 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.

Source page: https://510kreport.com/device/K962623
Methodology: https://510kreport.com/methodology