# K210805: Ceribell Instant EEG Headband

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: Aug 30, 2021 after 166 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: 5 generations back to K780045 (1978). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171459: Ceribell Instant EEG Headband, Ceribell, Inc. (2017) Summary page 4.
- K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), Wuhan Greentek Pty, Ltd. (2020) Summary page 4.

## Most influential descendants
- K232052: Ceribell Instant EEG Headband (2023), 3 descendants of its own
- 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
- K242930: Natus BrainWatch System (2024), 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 in patients of 2 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/K210805
Methodology: https://510kreport.com/methodology