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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 / March 2026 / K253772

510(k) cleared

Velocity Alpha MR High Speed Surgical Drill System

Adeor Medical AG · Mar 6, 2026 · K253772

FDA cleared the Velocity Alpha MR High Speed Surgical Drill System from Adeor Medical AG on Mar 6, 2026 under K253772, a traditional 510(k). The device falls under product code HBB, Motor, Drill, Pneumatic, regulated at 21 CFR 882.4370 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 26, 2025. The decision came 100 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 Adeor Medical AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253772?

K253772 is the FDA 510(k) for Velocity Alpha MR High Speed Surgical Drill System, submitted by Adeor Medical AG. FDA's decision date was Mar 6, 2026, under product code HBB (Motor, Drill, Pneumatic).

Who makes the Velocity Alpha MR High Speed Surgical Drill System?

Adeor Medical AG, based in Valley, is the applicant of record for K253772.

How long did the K253772 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Mar 6, 2026, 100 days later.

← All decisions in March 2026