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FDA 510(k)

Ceribell Instant EEG Headset

K-Number: K254033 · 2026-02-09

ApplicantCeribell, Inc.
Decision Date2026-02-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Instant EEG Headset is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2026-02-09 under 510(k) number K254033. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceribell Instant EEG Headset?

Ceribell Instant EEG Headset is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is Ceribell, Inc.. The 510(k) number is K254033.

When did Ceribell Instant EEG Headset receive FDA 510(k) clearance?

Ceribell Instant EEG Headset received FDA 510(k) clearance on 2026-02-09, under 510(k) number K254033.

Who is the listed applicant for Ceribell Instant EEG Headset?

The FDA 510(k) record lists Ceribell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceribell Instant EEG Headset?

The FDA product code for Ceribell Instant EEG Headset is GXY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07485244EEG Abnormalities in Adult ICU Patients With High Risk of DeliriumRECRUITINGNCT07449416Ceribell Delirium Monitor Outcomes Pilot StudyRECRUITING

Other records listing Ceribell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorK260998Ceribell Neurology Review SoftwareK260363Ceribell Brain Monitor HeadbandK251936Ceribell Delirium Monitor SystemK252070Ceribell Infant Seizure Detection SoftwareK251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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