# K251582: Redermax Antibacterial Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Kreate Medical Co., Ltd.
- Decided: Feb 2, 2026 after 255 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: 4 generations back to K970566 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051647: Fortaderm Antimicrobial Wound Dressing, Organogenesis, Inc. (2005) Summary page 8.

## Most influential descendants
- K261646: Redermax® Antibacterial Wound Matrix (2026), 0 descendants of its own

## 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, second-degree burns, and skin tears) Draining wounds.

Source page: https://510kreport.com/device/K251582
Methodology: https://510kreport.com/methodology