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510(k) K254033

Ceribell Instant EEG Headset by Ceribell, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2026
Date Received
December 16, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Ceribell, Inc.

  • 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)

Other clearances for product code GXY

  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)
  • K242346 — Grass® MR Conditional/CT Cup Electrodes (August 29, 2024)