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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OMB FDA class 2

    Automatic Event Detection Software For Full-Montage Electroencephalograph

    Neurology

    View full classification →

    The Automatic Event Detection Software For Full-Montage Electroencephalograph (product code OMB) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It automatically marks or identifies EEG waveforms for spikes, electrographic seizures, and seizure-like events to aid in reviewing and annotating prolonged EEG traces, with all output subject to verification by a qualified user. The device is not eligible for third-party review and is not an implant or life-sustaining device.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    Ceribell Infant Seizure Detection Software
    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
    Ceribell Seizure Detection Software
    autoSCORE (V 2.0.0)
    Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
    NeuroMatch
    REMI-AI Rapid Detection Module (REMI-AI RDM)
    encevis (2.1)
    autoSCORE
    REMI AI Discrete Detection Module
    LVIS NeuroMatch
    Ceribell Status Epilepticus Monitor
    Persyst 15 EEG Review and Analysis Software
    Encevis
    Natus NeuroWorks
    Ceribell Pocket EEG Device
    Persyst 14 EEG Review and Analysis Software
    encevis
    Natus NeuroWorks
    Persyst Mobile App
    IdentEvent
    PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
    CLINISCANSM EEG
    CADWELL SPIKE AND SEIZURE DETECTOR
    PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
    PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
    ICTA
    NATUS NEUROWORKS, MODEL 104196
    IDENTEVENT, VERSION 1.0G
    XLTEK CONNEX IP HEADBOX, MODEL 1054
    PERSYST REVEAL
    EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
    EEG SPIKE AND EVENT DETECTOR MODULE
    HARMONIE SENSA
    DIGITRACE HOME VIDEO SYSTEM
    BIO-LOGIC AUTOMATIC EVENT ANALYSIS
    NMI SOFTWARE
    DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
    PERSYST SPIKE DETECTOR
    DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
    SZAC-16 SEIZURE ANALYSIS COMPUTER

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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