# K261646: Redermax® Antibacterial Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Kreate Medical Co., Ltd.
- Decided: Aug 14, 2026 after 88 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: 5 generations back to K970566 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251582: Redermax Antibacterial Wound Matrix, Beijing Kreate Medical Co., Ltd. (2026) Summary page 5.

## Indications for use
Redermax Antibacterial Wound Matrix is intended for the management of wounds. Redermax Antibacterial Wound Matrix is indicated for the management of: • Partial and full thickness wounds • Pressure ulcers • Venous ulcers • Diabetic ulcers • Chronic vascular ulcers • Tunneled/undermined wounds • Surgical wounds (donor sites/grafts, post-Mohs' 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/K261646
Methodology: https://510kreport.com/methodology