Chrysalis Intelligence · Sponsors · Ceribell, Inc.

Ceribell, Inc.

Sunnyvale, CA, US · 12 510(k) clearances

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Total clearances
12
2021-08-30 → 2026-06-30
Last 12 months
7
Product codes
4
Most recent
2026-06-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GXY Electrode, Cutaneous Class II Neurology 6 2026-04-03
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Class II Neurology 4 2026-06-24
OMC Reduced- Montage Standard Electroencephalograph Class II Neurology 1 2026-06-30
NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid Class II Neurology 1 2025-12-08
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2026-06-30 K261101 Ceribell Monitor OMC Class II Neurology
2026-06-24 K260998 Ceribell Neurology Review Software OMB Class II Neurology
2026-04-03 K260363 Ceribell Brain Monitor Headband GXY Class II Neurology
2026-02-09 K254033 Ceribell Instant EEG Headset GXY Class II Neurology
2025-12-08 K251936 Ceribell Delirium Monitor System NCG Class II Neurology
2025-11-21 K252070 Ceribell Infant Seizure Detection Software OMB Class II Neurology
2025-10-31 K251381 Ceribell Instant EEG Headcap (Small: C251, Medium: C252) GXY Class II Neurology
2025-04-09 K241589 Ceribell Seizure Detection Software OMB Class II Neurology
2023-08-08 K232052 Ceribell Instant EEG Headband GXY Class II Neurology
2023-05-23 K223504 Ceribell Status Epilepticus Monitor OMB Class II Neurology
2023-03-22 K223086 Ceribell Instant EEG Headcap GXY Class II Neurology
2021-08-30 K210805 Ceribell Instant EEG Headband GXY Class II Neurology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence