# K261712: Ceribell EEG Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Sep 16, 2026 after 117 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240993: encevis (2.1), Ait Austrian Institute of Technology GmbH (2024) Summary page 5.

## Indications for use
The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The included aEEG functionality is intended to monitor the state of the brain.

Source page: https://510kreport.com/device/K261712
Methodology: https://510kreport.com/methodology