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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 / November 2025 / K252704

510(k) cleared

F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)

F Care Systems USA, LLC · Nov 24, 2025 · K252704

FDA cleared the F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) from F Care Systems USA, LLC on Nov 24, 2025 under K252704, 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 Aug 27, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

F Care Systems USA, LLC has 2 other decisions in the tracker over the last 12 months: K260161 (SmartGuide Disposable Guides and Grids), K253918 (Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)).

Questions & Answers

What did FDA clear under K252704?

K252704 is the FDA 510(k) for F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St), submitted by F Care Systems USA, LLC. FDA's decision date was Nov 24, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)?

F Care Systems USA, LLC, based in Miami, FL, is the applicant of record for K252704.

How long did the K252704 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Nov 24, 2025, 89 days later.

← All decisions in November 2025

Sources