Ceribell Delirium Monitor System
FDA 510(k) K251936 · Ceribell, Inc.
510(k) numberK251936
Submission
- Device name
- Ceribell Delirium Monitor System
- Applicant
- Ceribell, Inc.
Sunnyvale, CA, US - Received
- June 24, 2025
- Decision date
- December 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NCG – Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1440
- Specialty
- Neurology
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."
Other 510(k)s with product code NCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222680 | DeltaScan MonitorNCG · Traditional | Prolira B.V. | 02/02/2023SE |
More from Prolira B.V.
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| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | 04/03/2026SE |
| K254033 | Ceribell Instant EEG HeadsetGXY · Abbreviated | 02/09/2026SE |
| 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 Delirium Monitor System cleared by the FDA?
Ceribell Delirium Monitor System (K251936) received a 510(k) decision of Substantially Equivalent on December 8, 2025, 167 days after the submission was received.
What is the product code of K251936?
The FDA product code is NCG – Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, a Class II (moderate risk) device regulated under 21 CFR 882.1440.