BCIwiki (bciwiki.com) — Ceribell, Inc. received an FDA 510(k) decision of Substantially Equivalent for Ceribell Delirium Monitor System on December 8, 2025, under submission number K251936. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Neuropsychiatric Interpretative Electroencephalograph Assessment Aid. It is a Class 2 device under regulation number 882.1440, assigned to the Neurology advisory committee. The classification 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.