Ceribell, Inc.
Sunnyvale, CA, US
CERIBELL, INC. appears in FDA device records in Sunnyvale, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Ceribell, Inc. between 2017 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2025 | 4 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261101 | Ceribell Monitor | OMC | Substantially Equivalent | |
| K260998 | Ceribell Neurology Review Software | OMB | Substantially Equivalent | |
| K260363 | Ceribell Brain Monitor Headband | GXY | Substantially Equivalent | |
| K254033 | Ceribell Instant EEG Headset | GXY | Substantially Equivalent | |
| K251936 | Ceribell Delirium Monitor System | NCG | Substantially Equivalent | |
| K252070 | Ceribell Infant Seizure Detection Software | OMB | Substantially Equivalent | |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | GXY | Substantially Equivalent | |
| K241589 | Ceribell Seizure Detection Software | OMB | Substantially Equivalent | |
| K232052 | Ceribell Instant EEG Headband | GXY | Substantially Equivalent | |
| K223504 | Ceribell Status Epilepticus Monitor | OMB | Substantially Equivalent | |
| K223086 | Ceribell Instant EEG Headcap | GXY | Substantially Equivalent | |
| K210805 | Ceribell Instant EEG Headband | GXY | Substantially Equivalent | |
| K191301 | Ceribell Pocket EEG Device | OMB | Substantially Equivalent | |
| K171459 | Ceribell Instant EEG Headband | GXY | Substantially Equivalent | |
| K170363 | Ceribell Pocket EEG Device | OMC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013671918 | 3013671918 | CERIBELL, INC. | 360 N Pastoria Ave, Sunnyvale, CA 94085 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain