# K251936: Ceribell Delirium Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Dec 8, 2025 after 167 days
- Product code: NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K780045 (1978). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222680: DeltaScan Monitor, Prolira B.V. (2023) Summary page 5.
- K191301: Ceribell Pocket EEG Device, Ceribell, Inc. (2019) Summary page 5.
- K232052: Ceribell Instant EEG Headband, Ceribell, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251936
Methodology: https://510kreport.com/methodology