Home / 510(k) Clearances / K252070

510(k) K252070

Ceribell Infant Seizure Detection Software by Ceribell, Inc. — Product Code OMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2025
Date Received
July 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

Other clearances by Ceribell, Inc.

  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251936 — Ceribell Delirium Monitor System (December 8, 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 OMB

  • K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (October 31, 2025)
  • K241589 — Ceribell Seizure Detection Software (April 9, 2025)
  • K243743 — autoSCORE (V 2.0.0) (April 9, 2025)
  • K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (January 22, 2025)
  • K241390 — NeuroMatch (November 26, 2024)
  • K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) (October 17, 2024)
  • K240993 — encevis (2.1) (September 27, 2024)
  • K231068 — autoSCORE (January 7, 2024)
  • K231779 — REMI AI Discrete Detection Module (January 3, 2024)
  • K222450 — LVIS NeuroMatch (June 9, 2023)