Ceribell Monitor
FDA 510(k) K261101 · Ceribell, Inc.
510(k) numberK261101
Submission
- Device name
- Ceribell Monitor
- Applicant
- Ceribell, Inc.
Sunnyvale, CA, US - Received
- April 2, 2026
- Decision date
- June 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMC – Reduced- Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Other 510(k)s with product code OMC
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|---|---|---|---|
| K251550 | NX01 (NX01)OMC · Traditional | Naox Technologies Sas | 11/25/2025SE |
| K251726 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/03/2025SE |
| K243185 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel | 03/21/2025SE |
| K242930 | Natus BrainWatch SystemOMC · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 11/19/2024SE |
| K232779 | Quex Ed; Quex SOMC · Traditional | Qx World, Ltd. | 10/11/2024SE |
| K242306 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/04/2024SE |
| K230933 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel, Inc. | 06/30/2023SE |
| K223628 | NEBA® Compact EEG2R Mobile HeadsetOMC · Traditional | Neba Health, LLC | 03/02/2023SE |
| K221563 | Neurosteer EEG RecorderOMC · Traditional | Neurosteer, Inc. | 10/24/2022SE |
| K203827 | RemiOMC · Traditional | Epitel, Inc. | 03/29/2021SE |
More from Epitel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260998 | Ceribell Neurology Review SoftwareOMB · Traditional | 06/24/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | 04/03/2026SE |
| K254033 | Ceribell Instant EEG HeadsetGXY · Abbreviated | 02/09/2026SE |
| K251936 | Ceribell Delirium Monitor SystemNCG · Traditional | 12/08/2025SE |
| K252070 | Ceribell Infant Seizure Detection SoftwareOMB · Traditional | 11/21/2025SE |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252)GXY · Abbreviated | 10/31/2025SE |
| K241589 | Ceribell Seizure Detection SoftwareOMB · Traditional | 04/09/2025SE |
| K232052 | Ceribell Instant EEG HeadbandGXY · Special | 08/08/2023SE |
| K223504 | Ceribell Status Epilepticus MonitorOMB · Traditional | 05/23/2023SE |
| K223086 | Ceribell Instant EEG HeadcapGXY · Abbreviated | 03/22/2023SE |
Questions and answers
When was Ceribell Monitor cleared by the FDA?
Ceribell Monitor (K261101) received a 510(k) decision of Substantially Equivalent on June 30, 2026, 89 days after the submission was received.
What is the product code of K261101?
The FDA product code is OMC – Reduced- Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.