# K254060: Life Saving Tourniquet

- Pathway: 510(k) (Traditional)
- Applicant: TW Medical
- Decided: Apr 3, 2026 after 107 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K002767 (2000). 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)
- K131561: Sam Junctional Tourniquet, Sam Medical Products (2013) Summary page 6.

## Indications for use
The LST – Life Saving Tourniquet is indicated for battlefield and trauma situations to: - Control difficult bleeds in the inguinal area. - Control difficult bleeds in the axilla area.

Source page: https://510kreport.com/device/K254060
Methodology: https://510kreport.com/methodology