# K250319: Mfuse (MS001)

- Pathway: 510(k) (Traditional)
- Applicant: Machina Medical, Inc.
- Decided: Dec 15, 2025 after 314 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 6 generations back to K002550 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240713: Traumagel®, Cresilon, Inc. (2024) Summary page 5.

## Indications for use
MFUSE™ is indicated for temporary external use for controlling moderate to severe bleeding.

Source page: https://510kreport.com/device/K250319
Methodology: https://510kreport.com/methodology