Devices · Ceribell, Inc.

Ceribell Delirium Monitor System

Ceribell, Inc. is listed for Ceribell Delirium Monitor System (K251936). The FDA list gives December 8, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code NCG as “Neuropsychiatric Interpretative Electroencephalograph Assessment Aid”: Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis." openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251936

Official FDA database record

Date of final decision

December 8, 2025

Company on the FDA list

Ceribell, Inc.

Lead panel

Neurology

Primary product code

NCG

openFDA device name for the code

Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

Device class

2

Regulation number

882.1440

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary