# K171459: Ceribell Instant EEG Headband

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Aug 21, 2017 after 95 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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 K092828 (2010). 1 ancestor in all.
21 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092828: Statnet, Model 3100, Hydrodot, Inc. (2010) Summary page 4.

## Most influential descendants
- K183529: AE-120A EEG Head Set (2019), 9 descendants of its own
- K210805: Ceribell Instant EEG Headband (2021), 5 descendants of its own
- K202334: Neuronaute (2020), 4 descendants of its own
- K232052: Ceribell Instant EEG Headband (2023), 3 descendants of its own
- K203827: REMI (2021), 3 descendants of its own

## Indications for use
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 6 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

Source page: https://510kreport.com/device/K171459
Methodology: https://510kreport.com/methodology