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Ceribell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254033Ceribell Instant EEG HeadsetFebruary 9, 2026
K251936Ceribell Delirium Monitor SystemDecember 8, 2025
K252070Ceribell Infant Seizure Detection SoftwareNovember 21, 2025
K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)October 31, 2025
K241589Ceribell Seizure Detection SoftwareApril 9, 2025
K232052Ceribell Instant EEG HeadbandAugust 8, 2023
K223504Ceribell Status Epilepticus MonitorMay 23, 2023
K223086Ceribell Instant EEG HeadcapMarch 22, 2023
K210805Ceribell Instant EEG HeadbandAugust 30, 2021
K191301Ceribell Pocket EEG DeviceSeptember 11, 2019
K171459Ceribell Instant EEG HeadbandAugust 21, 2017
K170363Ceribell Pocket EEG DeviceMay 8, 2017