# K170363: Ceribell Pocket EEG Device

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: May 8, 2017 after 91 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: 1 generation back to K830295 (1983). 1 ancestor in all.
25 later devices descend from it; 7 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830295: Medilog 9000 System, Oxford Medilog, Inc. (1983) Summary page 4.

## Most influential descendants
- K183529: AE-120A EEG Head Set (2019), 9 descendants of its own
- K191301: Ceribell Pocket EEG Device (2019), 8 descendants of its own
- K202334: Neuronaute (2020), 4 descendants of its own
- K223504: Ceribell Status Epilepticus Monitor (2023), 3 descendants of its own
- K203827: REMI (2021), 3 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 does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

Source page: https://510kreport.com/device/K170363
Methodology: https://510kreport.com/methodology