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FDA 510(k)

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

K-Number: K251381 · 2025-10-31

ApplicantCeribell, Inc.
Decision Date2025-10-31
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2025-10-31 under approval number K251381. 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 Headcap (Small: C251, Medium: C252)?

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Ceribell, Inc.. The 510(k) number is K251381.

When was Ceribell Instant EEG Headcap (Small: C251, Medium: C252) approved by the FDA?

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) received FDA 510(k) clearance on 2025-10-31, under approval number K251381.

What company makes Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is manufactured by Ceribell, Inc..

What is the FDA product code for Ceribell Instant EEG Headcap (Small: C251, Medium: C252)?

The FDA product code for Ceribell Instant EEG Headcap (Small: C251, Medium: C252) is GXY.

Related Clinical Trials

NCT04607343 Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea SUSPENDED

Related PubMed Literature

PMID: 41123878 Medical devices in Europe, all but drugs: time to radically change their regulation? Internal and emergency medicine (2026)

Other Devices by Ceribell, Inc.

K171459Ceribell Instant EEG Headband K170363Ceribell Pocket EEG Device K191301Ceribell Pocket EEG Device K210805Ceribell Instant EEG Headband K232052Ceribell Instant EEG Headband K223504Ceribell Status Epilepticus Monitor

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Related Devices (Code: GXY)

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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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