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THE TAPE

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 / K252070

510(k) cleared

Ceribell Infant Seizure Detection Software

Ceribell, Inc. · Nov 21, 2025 · K252070

FDA cleared the Ceribell Infant Seizure Detection Software from Ceribell, Inc. on Nov 21, 2025 under K252070, a traditional 510(k). The device falls under product code OMB, Automatic Event Detection Software For Full-Montage Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 1, 2025. The decision came 143 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K254033 (Ceribell Instant EEG Headset).

Questions & Answers

What did FDA clear under K252070?

K252070 is the FDA 510(k) for Ceribell Infant Seizure Detection Software, submitted by Ceribell, Inc.. FDA's decision date was Nov 21, 2025, under product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph).

Who makes the Ceribell Infant Seizure Detection Software?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K252070.

How long did the K252070 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Nov 21, 2025, 143 days later.

← All decisions in November 2025