K251936 is an FDA 510(k) clearance for the Ceribell Delirium Monitor System. This device is classified as a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (Class II - Special Controls, product code NCG).
Submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 8, 2025, 167 days after receiving the submission on June 24, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1440. 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.".
| 510(k) Number | K251936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2025 |
| Decision Date | December 08, 2025 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NCG - Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1440 |
| Definition | 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." |