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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 / October 2025 / K251185

510(k) cleared

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

Intervene · Oct 22, 2025 · K251185

FDA cleared the Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) from Intervene on Oct 22, 2025 under K251185, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 16, 2025. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Intervene in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251185?

K251185 is the FDA 510(k) for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020), submitted by Intervene. FDA's decision date was Oct 22, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

Intervene, based in Redwood City, CA, is the applicant of record for K251185.

How long did the K251185 review take?

FDA received the submission on Apr 16, 2025 and issued its decision on Oct 22, 2025, 189 days later.

← All decisions in October 2025