Life Saving Tourniquet— 510(k) K254060
Substantially EquivalentTW Medical
FDA 510(k) clearance K254060 for Life Saving Tourniquet, Substantially Equivalent on 2026-04-03. Applicant: TW Medical. Device class: 2.
Summary
TW Medical's Life Saving Tourniquet is filed under product code DXC (Clamp, Vascular). The record doesn't describe the tourniquet beyond its name and that code name.
Class II, 21 CFR 870.4450. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
TW Medical filed from Otniel, Israel. Review took 107 calendar days (December 17, 2025 to April 3, 2026).
Clearance details
- Applicant
- TW Medical
- Product code
- Product code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otniel, IL
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
Adverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.