Ceribell, Inc. - FDA 510(k) Cleared Devices

Cleared Jun 24, 2026

Ceribell Neurology Review Software

K260998 · OMB

Neurology · 90d

Cleared Apr 03, 2026

Ceribell Brain Monitor Headband

K260363 · GXY

Neurology · 58d

Cleared Feb 09, 2026

Ceribell Instant EEG Headset

K254033 · GXY

Neurology · 55d

Cleared Dec 08, 2025

Ceribell Delirium Monitor System

K251936 · NCG

Neurology · 167d

Cleared Nov 21, 2025

Ceribell Infant Seizure Detection Software

K252070 · OMB

Neurology · 143d

Cleared Oct 31, 2025

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

K251381 · GXY

Neurology · 182d

Cleared Apr 09, 2025

Ceribell Seizure Detection Software

K241589 · OMB

Neurology · 310d

Cleared Aug 08, 2023

Ceribell Instant EEG Headband

K232052 · GXY

Neurology · 29d

Cleared May 23, 2023

Ceribell Status Epilepticus Monitor

K223504 · OMB

Neurology · 182d

Cleared Mar 22, 2023

Ceribell Instant EEG Headcap

K223086 · GXY

Neurology · 173d

Cleared Aug 30, 2021

Ceribell Instant EEG Headband

K210805 · GXY

Neurology · 166d

Cleared Sep 11, 2019

Ceribell Pocket EEG Device

K191301 · OMB

Neurology · 120d