WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252071

510(k) cleared

RefleXion Medical Radiotherapy System, Reflexion X2

Reflexion Medical, Inc. · Dec 18, 2025 · K252071

FDA cleared the RefleXion Medical Radiotherapy System, Reflexion X2 from Reflexion Medical, Inc. on Dec 18, 2025 under K252071, a traditional 510(k). The device falls under product code QVA, Fludeoxyglucose F18-Guided Radiation Therapy System, regulated at 21 CFR 892.5060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 1, 2025. The decision came 170 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 Reflexion Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252071?

K252071 is the FDA 510(k) for RefleXion Medical Radiotherapy System, Reflexion X2, submitted by Reflexion Medical, Inc.. FDA's decision date was Dec 18, 2025, under product code QVA (Fludeoxyglucose F18-Guided Radiation Therapy System).

Who makes the RefleXion Medical Radiotherapy System, Reflexion X2?

Reflexion Medical, Inc., based in Hayward, CA, is the applicant of record for K252071.

How long did the K252071 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Dec 18, 2025, 170 days later.

← All decisions in December 2025