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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 / July 2026 / K254006

510(k) cleared

Drivewire 35 Guidewire

Rapid Medical Ltd. · Jul 17, 2026 · K254006

FDA cleared the Drivewire 35 Guidewire from Rapid Medical Ltd. on Jul 17, 2026 under K254006, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 15, 2025. The decision came 214 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rapid Medical Ltd. has 3 other decisions in the tracker over the last 12 months: K253146 (Hyperdrive 35 Guidewire), K260617 (Tigertriever 13 Ultra Revascularization Device), K253062 (Tigertriever 25 Revascularization Device).

Questions & Answers

What did FDA clear under K254006?

K254006 is the FDA 510(k) for Drivewire 35 Guidewire, submitted by Rapid Medical Ltd.. FDA's decision date was Jul 17, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Drivewire 35 Guidewire?

Rapid Medical Ltd., based in Yokneam, is the applicant of record for K254006.

How long did the K254006 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jul 17, 2026, 214 days later.

← All decisions in July 2026

Sources