# K260998: Ceribell Neurology Review Software

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Jun 24, 2026 after 90 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K243743: autoSCORE (V 2.0.0), Holberg Eeg AS (2025) Summary page 5.

## Indications for use
The Ceribell Neurology Review Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists 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 Artifact Reduction component is intended to reduce artifact in EEG recordings. The Artifact Reduction component does not remove the entire artifact signal and may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified clinical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms. The Epileptiform Abnormality Detection component is intended to mark previously acquired sections of the patient’s EEG recordings that may correspond to epileptiform abnormalities in order to assist qualified clinical practitioners in the assessment of EEG traces. The Epileptiform Abnormality Detection component is intended to be used in patients at least one year old.

Source page: https://510kreport.com/device/K260998
Methodology: https://510kreport.com/methodology