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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: OLV FDA class 2

    Standard Polysomnograph With Electroencephalograph

    Neurology

    View full classification →

    The Standard Polysomnograph With Electroencephalograph (product code OLV) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It is designed to acquire, display, store, and archive electroencephalographic signals from the brain along with other physiological signals such as electromyography, respiratory data, and oximetry for sleep recordings, and may support on-screen review and annotation by clinicians. The device is eligible for third-party review and is not an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Falcon HST
    Noxturnal Web
    HomeSleepTest (HST, HST REM+)
    Cerebra Sleep System
    SOMNOscreen plus
    ApneaTrak
    Serenity Piezo Sensor, Serenity Thermocouple Sensor
    Serenity Body Position Sensor, Serenity RIP Sensors
    Grass TWin
    Zmachine Synergy
    Comet-PLUS
    Polysmith Sleep System, Model NTI7593
    Polysmith Sleep System
    LIVE VIEW PANEL (LVP)
    GALAXY SYSTEM; JUPITER
    ZMACHINE, MODEL DT-100
    BE MICRO, TREA
    EEG-1100A SWITCH BOX
    MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
    AURA-PSG
    CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
    ELECTRODE JUNCTION BOX, MODEL JE-921A
    OMNIPRO SYSTEM
    FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
    PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
    WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
    MEDIPALM-20
    NIGHTRON POLYSOMNOGRAPHY SYSTEM
    XLTEK SLEEP SYSTEM
    GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
    PSG INPUT BOX, MODEL JE-912AK
    NERVUS MONITOR
    TWIN PLUS
    NOTTA AMBULATORY RECORDER
    SOMNO STAR & SERIES SLEEP SYSTEM
    HARMONE-SCHWARZER EEG SYSTEM
    LIFELINES TRACKIT
    NEUROFAX, MODELS EEG-1100A, EEG-9100A
    COMPUMEDICS SIESTA SYSTEM
    BIO-LOGIC SLEEPSCAN NETLINK
    MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
    VITAPORT 3
    GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
    NEUROFAX, MODEL EEG-1100A
    ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
    H20- TETHERED OPTION
    BIOSACA SYSTEM, MODEL 800
    XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
    WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
    BIOSACA SYSTEM

    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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