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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 / January 2026 / K254010

510(k) cleared

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Brainlab SE · Jan 14, 2026 · K254010

FDA cleared the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface from Brainlab SE on Jan 14, 2026 under K254010, a special 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 15, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Brainlab SE has 2 other decisions in the tracker over the last 12 months: K252476 (Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout), K252562 (Spine & Trauma Navigation Instruments).

Questions & Answers

What did FDA clear under K254010?

K254010 is the FDA 510(k) for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface, submitted by Brainlab SE. FDA's decision date was Jan 14, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

Brainlab SE, based in Munich, is the applicant of record for K254010.

How long did the K254010 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jan 14, 2026, 30 days later.

← All decisions in January 2026

Sources