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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 / K250423

510(k) cleared

mb-FIX Cranial Stabilization Systems

Medical Bees GmbH · Nov 6, 2025 · K250423

FDA cleared the mb-FIX Cranial Stabilization Systems from Medical Bees GmbH on Nov 6, 2025 under K250423, a traditional 510(k). The device falls under product code HBL, Holder, Head, Neurosurgical (Skull Clamp), regulated at 21 CFR 882.4460 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 14, 2025. The decision came 265 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 Medical Bees GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250423?

K250423 is the FDA 510(k) for mb-FIX Cranial Stabilization Systems, submitted by Medical Bees GmbH. FDA's decision date was Nov 6, 2025, under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)).

Who makes the mb-FIX Cranial Stabilization Systems?

Medical Bees GmbH, based in Emmingen-Liptingen, is the applicant of record for K250423.

How long did the K250423 review take?

FDA received the submission on Feb 14, 2025 and issued its decision on Nov 6, 2025, 265 days later.

← All decisions in November 2025