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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 / June 2026 / K261101

510(k) cleared

Ceribell Monitor

Ceribell, Inc. · Jun 30, 2026 · K261101

FDA cleared the Ceribell Monitor from Ceribell, Inc. on Jun 30, 2026 under K261101, a traditional 510(k). The device falls under product code OMC, Reduced- Montage Standard Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 2, 2026. The decision came 89 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: K260998 (Ceribell Neurology Review Software), K260363 (Ceribell Brain Monitor Headband), K254033 (Ceribell Instant EEG Headset), K251936 (Ceribell Delirium Monitor System).

Questions & Answers

What did FDA clear under K261101?

K261101 is the FDA 510(k) for Ceribell Monitor, submitted by Ceribell, Inc.. FDA's decision date was Jun 30, 2026, under product code OMC (Reduced- Montage Standard Electroencephalograph).

Who makes the Ceribell Monitor?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K261101.

How long did the K261101 review take?

FDA received the submission on Apr 2, 2026 and issued its decision on Jun 30, 2026, 89 days later.

← All decisions in June 2026