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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 / 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 2 other decisions in the tracker over the last 12 months: K253062 (Tigertriever 25 Revascularization Device), K251603 (Tigertriever 17 Ultra 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