BCIwiki (bciwiki.com) — Ceribell, Inc. received an FDA 510(k) decision of Substantially Equivalent for Ceribell Neurology Review Software on June 24, 2026, under submission number K260998. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Automatic Event Detection Software For Full-Montage Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. The classification covers software that automatically flags events within full-montage EEG recordings, surfacing candidate segments from long records for clinician review.