# K191301: Ceribell Pocket EEG Device

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Sep 11, 2019 after 120 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: 2 generations back to K830295 (1983). 3 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 12 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 4.
- K151929: Persyst 13 (P13) Eeg Review and Analysis Software, Persyst Development Corporation (2015) Summary page 4.

## Most influential descendants
- K223504: Ceribell Status Epilepticus Monitor (2023), 3 descendants of its own
- K240993: encevis (2.1) (2024), 2 descendants of its own
- K241589: Ceribell Seizure Detection Software (2025), 1 descendant of its own
- K261712: Ceribell EEG Analysis Software (2026), 0 descendants of its own
- K260998: Ceribell Neurology Review Software (2026), 0 descendants of its own

## Indications for use
The Ceribell Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment. Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component 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. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user. The Pocket EEG Device 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 trained expert.

Source page: https://510kreport.com/device/K191301
Methodology: https://510kreport.com/methodology