| K-number | K254033 |
| Device name | Ceribell Instant EEG Headset |
| Applicant | Ceribell, Inc. |
| Product code | GXY |
| Device class | Class II |
| Decision date | Feb 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.1320 |
The Ceribell Instant EEG Headset is a single-use, disposable EEG electrode device containing up to 20 passive silver/silver chloride electrodes mounted on an elastic fabric headset. It is intended for rapid placement of EEG electrodes in routine clinical settings to collect and transmit EEG signals to a recording or monitoring device.
The subject device uses the same Ag/AgCl electrode technology, conductive electrolyte gel reservoirs, spandex blend fabric headset, and integrated cable as the predicate devices. It supports up to 20 electrodes compared to 10 in the primary predicate and 9–19 in the secondary predicate, and is sized for head circumferences of 45.1–62.0 cm, matching the primary predicate's size range.
ANSI/AAMI EC12 (Disposable ECG Electrodes) for electrical performance; IEC 60601-2-2 for shelf-life; ANSI/AAMI ES 60601-1 clause 8.5.2.3 for conductive connection compliance; ISO 10993-1, 10993-5, 10993-10, and 10993-23 for biocompatibility; and FDA's August 2020 guidance on Cutaneous Electrodes for Recording Purposes.
The subject device has identical intended use, principle of operation, patient contact materials, and electrical performance specifications as both predicate devices. The differences in electrode count and form factor (headset versus headband/headcap) do not raise new safety or effectiveness questions, and performance data demonstrate acceptable biocompatibility and electrical characteristics equivalent to the predicates.
View the full FDA submission: accessdata.fda.gov