Ceribell

The FDA cleared the Ceribell Monitor on June 30, 2026, finding it substantially equivalent under submission number K261101 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. It is one of several Ceribell clearances in the same period; the product line is built around rapid reduced-montage setup for bedside recording in emergency and critical care.

The FDA cleared the Ceribell Neurology Review Software on June 24, 2026, finding it substantially equivalent under submission number K260998 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings, surfacing candidate segments from long records for clinician review.

The FDA cleared the Ceribell Delirium Monitor System on December 8, 2025, finding it substantially equivalent under submission number K251936 through the traditional 510(k) pathway. The agency classifies it as a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, a Class II device under regulation 882.1440, with neurology as the assigned review panel. The category covers devices that derive neuropsychiatric assessments from EEG signals; Ceribell's earlier products in this line target seizure monitoring in emergency and intensive care settings.

The US Food and Drug Administration cleared Ceribell, Inc.'s Ceribell Infant Seizure Detection Software on November 21, 2025, finding it substantially equivalent under submission number K252070 via the Traditional 510(k) pathway. FDA lists it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Neonatal EEG looks markedly different from adult morphology, which has long made automated interpretation difficult; the classification covers software that flags events automatically in full-montage recordings.