# K253204: Catalyze

- Pathway: 510(k) (Traditional)
- Applicant: BioTissue Holdings, Inc.
- Decided: Jun 5, 2026 after 252 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: 9 generations back to K921895 (1992). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231325: Corplex P / Theracor P / Allacor P, Stimlabs, LLC (2024) Summary page 5.

## Indications for use
Catalyze is indicated for use in the management of the following wounds: • 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, partial-thickness burns, and skin tears) • Draining Wounds

Source page: https://510kreport.com/device/K253204
Methodology: https://510kreport.com/methodology