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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 / April 2026 / K260363

510(k) cleared

Ceribell Brain Monitor Headband

Ceribell, Inc. · Apr 3, 2026 · K260363

FDA cleared the Ceribell Brain Monitor Headband from Ceribell, Inc. on Apr 3, 2026 under K260363, a abbreviated 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 4, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Ceribell, Inc. has 6 other decisions in the tracker over the last 12 months: K261101 (Ceribell Monitor), K260998 (Ceribell Neurology Review Software), K254033 (Ceribell Instant EEG Headset), K251936 (Ceribell Delirium Monitor System).

Questions & Answers

What did FDA clear under K260363?

K260363 is the FDA 510(k) for Ceribell Brain Monitor Headband, submitted by Ceribell, Inc.. FDA's decision date was Apr 3, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Ceribell Brain Monitor Headband?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K260363.

How long did the K260363 review take?

FDA received the submission on Feb 4, 2026 and issued its decision on Apr 3, 2026, 58 days later.

← All decisions in April 2026