Ceribell Delirium Monitor System
FDA 510(k) clearance K251936 · decided 2025-12-08
Clearance details
- K-number
- K251936
- Device name
- Ceribell Delirium Monitor System
- Applicant
- Ceribell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-24
- Decision date
- 2025-12-08
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- NCG
- Device class
- 2
- Regulation number
- 882.1440
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DeltaScan Monitor (K222680) | Prolira B.V. | 2023-02-02 |
| NEBA SYSTEM (DEN110019) | Lexicor Medical Technology, LLC | 2013-07-15 |
Recalls involving this device
No recalls on record reference this clearance.