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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K254060

510(k) cleared

Life Saving Tourniquet

TW Medical · Apr 3, 2026 · K254060

FDA cleared the Life Saving Tourniquet from TW Medical on Apr 3, 2026 under K254060, a traditional 510(k). The device falls under product code DXC, Clamp, Vascular, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 17, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

TW Medical has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K254060?

K254060 is the FDA 510(k) for Life Saving Tourniquet, submitted by TW Medical. FDA's decision date was Apr 3, 2026, under product code DXC (Clamp, Vascular).

Who makes the Life Saving Tourniquet?

TW Medical, based in Otniel, is the applicant of record for K254060.

How long did the K254060 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Apr 3, 2026, 107 days later.

← All decisions in April 2026