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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 / February 2026 / K254033

510(k) cleared

Ceribell Instant EEG Headset

Ceribell, Inc. · Feb 9, 2026 · K254033

FDA cleared the Ceribell Instant EEG Headset from Ceribell, Inc. on Feb 9, 2026 under K254033, 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 Dec 16, 2025. The decision came 55 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), K260363 (Ceribell Brain Monitor Headband), K251936 (Ceribell Delirium Monitor System).

Questions & Answers

What did FDA clear under K254033?

K254033 is the FDA 510(k) for Ceribell Instant EEG Headset, submitted by Ceribell, Inc.. FDA's decision date was Feb 9, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Ceribell Instant EEG Headset?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K254033.

How long did the K254033 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Feb 9, 2026, 55 days later.

← All decisions in February 2026