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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 / December 2025 / K251936

510(k) cleared

Ceribell Delirium Monitor System

Ceribell, Inc. · Dec 8, 2025 · K251936

FDA cleared the Ceribell Delirium Monitor System from Ceribell, Inc. on Dec 8, 2025 under K251936, a traditional 510(k). The device falls under product code NCG, Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, regulated at 21 CFR 882.1440 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 24, 2025. The decision came 167 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 K251936?

K251936 is the FDA 510(k) for Ceribell Delirium Monitor System, submitted by Ceribell, Inc.. FDA's decision date was Dec 8, 2025, under product code NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid).

Who makes the Ceribell Delirium Monitor System?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K251936.

How long did the K251936 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Dec 8, 2025, 167 days later.

← All decisions in December 2025