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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: OLW FDA class 2

    Index-Generating Electroencephalograph Software

    Neurology

    View full classification →

    The Index-Generating Electroencephalograph Software (product code OLW) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It analyzes electrical activity of the brain by transforming electroencephalograph signals into a dimensionless index number intended for use and interpretation by a qualified clinical user. The device is not eligible for third-party review and is not an implant or life-sustaining device.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    BIS™ Advance Monitoring System
    Brain Anesthesia Response Monitor (Bar Monitor)
    Masimo SedLine Sedation Monitor and Accessories
    NeuroSENSE Monitoring System, Model NS-901
    SedLine Sedation Monitor
    Entropy Module, E-ENTROPY-01
    BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
    MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
    BIS EEG VISTA MONITOR SYSTEM AND BISX
    BIS MODULE FOR ENVOY PATIENT MONITOR
    BIS EEG MONITOR VIEW
    SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
    SNAP II EEG MONITOR
    BIS EEG MONITOR, MODEL BISX4
    BIS EEG MONITOR, MODEL A-3000
    SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
    DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
    DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
    CEREBRAL STATE MONITOR - CSM
    NARCOTREND, MODEL COMPACT 4.0
    BISX
    SEDLINE WITH FRONTAL PSI
    EEG MONITOR WITH BIS, MODEL A-2000
    MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
    DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
    PSA4000 EEG MONITOR WITH FRONTAL PSI
    SNAP EEG MONITOR
    DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
    BIS/EEG MODULE
    BIS ENGINE
    A-LINE AEP MONITOR
    EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
    AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
    BIS ENGINE
    MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
    A-2000 EEG MONITOR WITH BIS
    SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
    A-1000 EEG MONITOR AND A-1050 EEG MONITOR

    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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