# K223086: Ceribell Instant EEG Headcap

- Pathway: 510(k) (Abbreviated)
- Applicant: Ceribell, Inc.
- Decided: Mar 22, 2023 after 173 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). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), Wuhan Greentek Pty, Ltd. (2020) 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
- K251381: Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (2025), 0 descendants of its own

## Indications for use
The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

Source page: https://510kreport.com/device/K223086
Methodology: https://510kreport.com/methodology