ClearanceBrief
Company ยท US

Ceribell, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (7 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GXYElectrode, Cutaneous7
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph5
OMCReduced- Montage Standard Electroencephalograph2
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid1
OLTNon-Normalizing Quantitative Electroencephalograph Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 16, 2026K261712Ceribell EEG Analysis Software
Ceribell, Inc.
OLT
Jun 30, 2026K261101Ceribell Monitor
Ceribell, Inc.
OMC
Jun 24, 2026K260998Ceribell Neurology Review Software
Ceribell, Inc.
OMB
Apr 3, 2026K260363Ceribell Brain Monitor Headband
Ceribell, Inc.
GXY
Feb 9, 2026K254033Ceribell Instant EEG Headset
Ceribell, Inc.
GXY
Dec 8, 2025K251936Ceribell Delirium Monitor System
Ceribell, Inc.
NCG
Nov 21, 2025K252070Ceribell Infant Seizure Detection Software
Ceribell, Inc.
OMB
Oct 31, 2025K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
Ceribell, Inc.
GXY
Apr 9, 2025K241589Ceribell Seizure Detection Software
Ceribell, Inc.
OMB
Aug 8, 2023K232052Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
May 23, 2023K223504Ceribell Status Epilepticus Monitor
Ceribell, Inc.
OMB
Mar 22, 2023K223086Ceribell Instant EEG Headcap
Ceribell, Inc.
GXY
Aug 30, 2021K210805Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
Sep 11, 2019K191301Ceribell Pocket EEG Device
Ceribell, Inc.
OMB
Aug 21, 2017K171459Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
May 8, 2017K170363Ceribell Pocket EEG Device
Ceribell, Inc.
OMC

Latest recalls

DateFirm and productCodeLinked 510(k)
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