Ceribell, Inc.
Ceribell, Inc. appears in FDA public data with 0 recalls, 15 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 30, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 15
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261101 | Ceribell Monitor | June 30, 2026 |
| K260998 | Ceribell Neurology Review Software | June 24, 2026 |
| K260363 | Ceribell Brain Monitor Headband | April 3, 2026 |
| K254033 | Ceribell Instant EEG Headset | February 9, 2026 |
| K251936 | Ceribell Delirium Monitor System | December 8, 2025 |
| K252070 | Ceribell Infant Seizure Detection Software | November 21, 2025 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | October 31, 2025 |
| K241589 | Ceribell Seizure Detection Software | April 9, 2025 |
| K232052 | Ceribell Instant EEG Headband | August 8, 2023 |
| K223504 | Ceribell Status Epilepticus Monitor | May 23, 2023 |
| K223086 | Ceribell Instant EEG Headcap | March 22, 2023 |
| K210805 | Ceribell Instant EEG Headband | August 30, 2021 |
| K191301 | Ceribell Pocket EEG Device | September 11, 2019 |
| K171459 | Ceribell Instant EEG Headband | August 21, 2017 |
| K170363 | Ceribell Pocket EEG Device | May 8, 2017 |