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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

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