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Ceribell Seizure Detection Software (K241589)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241589

by Ceribell, Inc.

Identifiers

510(k) Number
K241589 FDA 510(k)
FDA Product Code
OMB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ceribell Seizure Detection Software is an Automatic Event Detection Software for Full-Montage Electroencephalograph, designed to identify and mark seizure activity in EEG recordings. Classified as a Class II medical device under FDA regulations, it processes continuous EEG data to detect epileptic events in patients aged one year or older. The software leverages algorithmic analysis to enhance neurological monitoring, supporting timely clinical intervention. Its integration with existing EEG systems ensures compatibility with standard diagnostic workflows.

This software is supplied as a digital solution, intended for use in clinical settings such as intensive care units (ICUs) and emergency departments (EDs). It operates on pre-acquired EEG recordings, requiring no additional hardware beyond a compatible EEG system. The device is not sterile and is intended for reusable use within authorized healthcare facilities. Regulatory clearance under FDA 510(k) (K241589) confirms its compliance with neurology-specific standards, ensuring reliability for seizure detection in acute care environments.

Frequently asked questions

What clinical environments is the Ceribell Seizure Detection Software designed to support, and how does it integrate with existing systems?

The Ceribell Seizure Detection Software is specifically designed for clinical settings like intensive care units (ICUs) and emergency departments (EDs), where continuous EEG monitoring is critical. It operates on pre-acquired EEG recordings from compatible full-montage EEG systems, meaning no additional hardware is required—just a seamless integration with your existing diagnostic workflows to enhance seizure detection.

Is the Ceribell Seizure Detection Software single-use or reusable, and what does that mean for its deployment in a hospital?

The software is intended for reusable use within authorized healthcare facilities. This means it can be repeatedly deployed across multiple patients and EEG recordings in a clinical setting, as long as it remains within the approved environment. Unlike disposable devices, it doesn’t require replacement after each use, making it cost-effective for ongoing monitoring.

What age group is the Ceribell Seizure Detection Software approved to analyze EEG recordings for seizure detection?

The software is designed to identify and mark seizure activity in EEG recordings for patients aged one year or older. This age restriction ensures its use aligns with clinical guidelines for pediatric and adult neurological monitoring in acute care settings.

How does the Ceribell Seizure Detection Software achieve its regulatory compliance, and what does that mean for reliability?

The software received FDA clearance under the 510(k) pathway (K241589), classified as substantially equivalent to a predicate device under neurology-specific standards. This clearance confirms its compliance with FDA requirements for automatic event detection in EEG systems, ensuring reliability and safety for clinical use in detecting epileptic events in real-time.

Does the Ceribell Seizure Detection Software require any special handling or storage conditions?

As a digital solution, the software does not require sterile packaging or specialized storage conditions like physical devices. However, it must be deployed within authorized healthcare facilities where it is intended for reuse, adhering to institutional IT and data security protocols to maintain its functionality and compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ceribell FAQs | Rapid EEG & Seizure Monitoring Solutions, Company - Ceribell, Ceribell Seizure Detection Software (K241589) — FDA 510 (k) | Innolitics, FDA Clears AI-Powered EEG for Seizure Detection

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ceribell, Inc.

Sources (1)

  • FDA 510(k) K241589 24 fields · synced Sep 20, 2026