BCIwiki (bciwiki.com) — Ceribell, Inc. received an FDA 510(k) decision of Substantially Equivalent for Ceribell Infant Seizure Detection Software on November 21, 2025, under submission number K252070. 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. Neonatal EEG differs markedly from adult morphology, making automated interpretation a long-standing clinical challenge; the classification covers software that automatically marks events in full-montage recordings.