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The Tracker / September 2026 / K261712

510(k) cleared

Ceribell EEG Analysis Software

Ceribell, Inc. · Sep 16, 2026 · K261712

FDA cleared the Ceribell EEG Analysis Software from Ceribell, Inc. on Sep 16, 2026 under K261712, a traditional 510(k). The device falls under product code OLT, Non-Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 22, 2026. The decision came 117 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ceribell, Inc. has 7 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 K261712?

K261712 is the FDA 510(k) for Ceribell EEG Analysis Software, submitted by Ceribell, Inc.. FDA's decision date was Sep 16, 2026, under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software).

Who makes the Ceribell EEG Analysis Software?

Ceribell, Inc., based in Sunnyvale, CA, is the applicant of record for K261712.

How long did the K261712 review take?

FDA received the submission on May 22, 2026 and issued its decision on Sep 16, 2026, 117 days later.

← All decisions in September 2026