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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 / December 2025 / K253091

510(k) cleared

ART-Plan+ (v3.1.0)

Therapanacea Sas · Dec 23, 2025 · K253091

FDA cleared the ART-Plan+ (v3.1.0) from Therapanacea Sas on Dec 23, 2025 under K253091, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 23, 2025. The decision came 91 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 Therapanacea Sas in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253091?

K253091 is the FDA 510(k) for ART-Plan+ (v3.1.0), submitted by Therapanacea Sas. FDA's decision date was Dec 23, 2025, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the ART-Plan+ (v3.1.0)?

Therapanacea Sas, based in Paris, is the applicant of record for K253091.

How long did the K253091 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Dec 23, 2025, 91 days later.

← All decisions in December 2025