# K232052: Ceribell Instant EEG Headband

- Pathway: 510(k) (Special)
- Applicant: Ceribell, Inc.
- Decided: Aug 8, 2023 after 29 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: 6 generations back to K780045 (1978). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210805: Ceribell Instant EEG Headband, Ceribell, Inc. (2021) Summary page 4.

## Most influential descendants
- K254033: Ceribell Instant EEG Headset (2026), 1 descendant of its own
- K260363: Ceribell Brain Monitor Headband (2026), 0 descendants of its own
- K251936: Ceribell Delirium Monitor System (2025), 0 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. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

Source page: https://510kreport.com/device/K232052
Methodology: https://510kreport.com/methodology