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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 / June 2026 / K253918

510(k) cleared

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)

F Care Systems USA, LLC · Jun 2, 2026 · K253918

FDA cleared the Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) from F Care Systems USA, LLC on Jun 2, 2026 under K253918, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 8, 2025. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

F Care Systems USA, LLC has 2 other decisions in the tracker over the last 12 months: K260161 (SmartGuide Disposable Guides and Grids), K252704 (F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)).

Questions & Answers

What did FDA clear under K253918?

K253918 is the FDA 510(k) for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St), submitted by F Care Systems USA, LLC. FDA's decision date was Jun 2, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)?

F Care Systems USA, LLC, based in Miami, FL, is the applicant of record for K253918.

How long did the K253918 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Jun 2, 2026, 176 days later.

← All decisions in June 2026

Sources