Ceribell Instant EEG Headset

About This 510(k) Submission

K254033 is an FDA 510(k) clearance for the Ceribell Instant EEG Headset, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 9, 2026, 55 days after receiving the submission on December 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.