# K211972: Omeza Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Omeza, LLC
- Decided: Sep 1, 2021 after 69 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 8 generations back to K881854 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182725: Apis, Sweetbio, Inc. (2019) Summary page 4.

## Indications for use
Omeza® Collagen Matrix is indicated 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 sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence) • Trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears) • Draining wounds The device is intended for one-time use.

Source page: https://510kreport.com/device/K211972
Methodology: https://510kreport.com/methodology