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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 / K253480

510(k) cleared

Capenergy C Equipments RF C200 and C400 Drakarian

Capenergy Medical S.L. · Jul 10, 2026 · K253480

FDA cleared the Capenergy C Equipments RF C200 and C400 Drakarian from Capenergy Medical S.L. on Jul 10, 2026 under K253480, a abbreviated 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, 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 Oct 14, 2025. The decision came 269 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 Capenergy Medical S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253480?

K253480 is the FDA 510(k) for Capenergy C Equipments RF C200 and C400 Drakarian, submitted by Capenergy Medical S.L.. FDA's decision date was Jul 10, 2026, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the Capenergy C Equipments RF C200 and C400 Drakarian?

Capenergy Medical S.L., based in Sant Joan Despi, is the applicant of record for K253480.

How long did the K253480 review take?

FDA received the submission on Oct 14, 2025 and issued its decision on Jul 10, 2026, 269 days later.

← All decisions in July 2026