# K261101: Ceribell Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Jun 30, 2026 after 89 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K830295 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170363: Ceribell Pocket EEG Device, Ceribell, Inc. (2017) Summary page 5.
- K231366: Neuronaute Plus, Bioserenity Sas (2023) Summary page 5.

## Indications for use
The Ceribell Monitor is intended to acquire, transmit, display and store electroencephalogram (EEG) and optionally electrocardiogram (ECG) and video. The Ceribell Monitor is intended for prescription use in professional healthcare facilities.

Source page: https://510kreport.com/device/K261101
Methodology: https://510kreport.com/methodology