WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / October 2025 / K251381

510(k) cleared

Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Ceribell, Inc. · Oct 31, 2025 · K251381

FDA cleared the Ceribell Instant EEG Headcap (Small: C251, Medium: C252) from Ceribell, Inc. on Oct 31, 2025 under K251381, 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 May 2, 2025. The decision came 182 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 K251381?

K251381 is the FDA 510(k) for Ceribell Instant EEG Headcap (Small: C251, Medium: C252), submitted by Ceribell, Inc.. FDA's decision date was Oct 31, 2025, under product code GXY (Electrode, Cutaneous).

Who makes the Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K251381.

How long did the K251381 review take?

FDA received the submission on May 2, 2025 and issued its decision on Oct 31, 2025, 182 days later.

← All decisions in October 2025