Neurology · 510(k) · 2025
Ceribell Delirium Monitor System
Ceribell, Inc.. Cleared by FDA on 8 December 2025 under submission K251936, product code NCG (neuropsychiatric interpretative electroencephalograph assessment aid). What FDA's record says, in FDA's words.
Device record · K251936
- Device. Ceribell Delirium Monitor SystemDEVICE
- Company. Ceribell, Inc.COMPANY
- Decision. 8 December 2025, 510(k), substantially equivalent (traditional review); received 24 June 2025DECISION
- Panel. NeurologyPANEL
- Product code. NCG, Neuropsychiatric Interpretative Electroencephalograph Assessment AidCODE
- Regulation. 21 CFR 882.1440, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K251936Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Ceribell Delirium Monitor System Please provide your Indications for Use below. The Ceribell Delirium Monitor System is intended to analyze features associated with diffuse slowing electroencephalogram (EEG) patterns that may be indicative of delirium. The Ceribell Delirium Monitor software is intended to aid in the screening and monitoring of delirium with clinical assessments in adult patients in critical care settings within hospitals. The Ceribell Delirium Monitor System analyzes discrete segments of EEG to notify clinicians when EEG patterns associated with delirium are detected while monitoring the patient. Changes in patient condition that are detected by the device should be verified before commencing any interventions. I
The product code's definition, from FDA's classification record. 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."
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code NCG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NCG, in Neurology, from Ceribell, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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