# K260363: Ceribell Brain Monitor Headband

- Pathway: 510(k) (Abbreviated)
- Applicant: Ceribell, Inc.
- Decided: Apr 3, 2026 after 58 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: 8 generations back to K780045 (1978). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K254033: Ceribell Instant EEG Headset, Ceribell, Inc. (2026). Cleared while this submission was under review Summary page 5.
- K232052: Ceribell Instant EEG Headband, Ceribell, Inc. (2023) Summary page 5.

## Indications for use
The Ceribell Brain Monitor Headband 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/K260363
Methodology: https://510kreport.com/methodology