# K241589: Ceribell Seizure Detection Software

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Apr 9, 2025 after 310 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: 3 generations back to K830295 (1983). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191301: Ceribell Pocket EEG Device, Ceribell, Inc. (2019) Summary page 5.

## Most influential descendants
- K252070: Ceribell Infant Seizure Detection Software (2025), 0 descendants of its own

## Indications for use
The Ceribell Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in patients greater or equal to 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant”, or "Continuous, per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Section notifications will be shown to a user. The Ceribell Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a training expert.

Source page: https://510kreport.com/device/K241589
Methodology: https://510kreport.com/methodology