# K251381: Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

- Pathway: 510(k) (Abbreviated)
- Applicant: Ceribell, Inc.
- Decided: Oct 31, 2025 after 182 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223086: Ceribell Instant EEG Headcap, Ceribell, Inc. (2023) Summary page 5.

## 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. The headcap shall be placed on the head of infants, including newborns and preterm babies.

Source page: https://510kreport.com/device/K251381
Methodology: https://510kreport.com/methodology