Ceribell Instant EEG Headset
FDA 510(k) K254033 · Ceribell, Inc.
510(k) numberK254033
Submission
- Device name
- Ceribell Instant EEG Headset
- Applicant
- Ceribell, Inc.
Sunnyvale, CA, US - Received
- December 16, 2025
- Decision date
- February 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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More from Bionit Labs Srl
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| K241589 | Ceribell Seizure Detection SoftwareOMB · Traditional | 04/09/2025SE |
| K232052 | Ceribell Instant EEG HeadbandGXY · Special | 08/08/2023SE |
| K223504 | Ceribell Status Epilepticus MonitorOMB · Traditional | 05/23/2023SE |
| K223086 | Ceribell Instant EEG HeadcapGXY · Abbreviated | 03/22/2023SE |
Questions and answers
When was Ceribell Instant EEG Headset cleared by the FDA?
Ceribell Instant EEG Headset (K254033) received a 510(k) decision of Substantially Equivalent on February 9, 2026, 55 days after the submission was received.
What is the product code of K254033?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.