# K240277: MiroDry Wound Matrix

- Pathway: 510(k) (Special)
- Applicant: Reprise Biomedical, Inc.
- Decided: Mar 1, 2024 after 30 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: 4 generations back to K061711 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223257: Miro3D Wound Matrix, Reprise Biomedical (2022) Summary page 4.

## Indications for use
The MiroDry Wound Matrix is intended for the management of wounds including: · Partial and full thickness wounds · Pressure ulcers · Venous ulcers · Chronic vascular ulcers · Diabetic ulcers · Tunneled, undermined wounds · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) · Draining wounds · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)

Source page: https://510kreport.com/device/K240277
Methodology: https://510kreport.com/methodology