# K253521: Ecmt-100 WMD

- Pathway: 510(k) (Traditional)
- Applicant: Ecm Therapeutics, Inc.
- Decided: Jun 18, 2026 after 217 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)
- K230980: MicroMatrix® Flex, Acell, Inc. (2023) Summary page 6.

## Indications for use
ECMT-100 WMD is intended 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-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), draining wounds. The device is intended for single-use.

Source page: https://510kreport.com/device/K253521
Methodology: https://510kreport.com/methodology