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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: MSX FDA class 2

    System, Network And Communication, Physiological Monitors

    Cardiovascular

    View full classification →

    A Physiological Monitor Network and Communication System is a device infrastructure that enables the transmission, reception, and management of patient physiological data between bedside monitors and central stations or other networked systems in clinical settings. It is classified as FDA Class 2, requiring 510(k) clearance, with product code MSX under 21 CFR 870.2300 in the Cardiovascular specialty, and is designated as life-sustaining due to its role in critical patient monitoring. The device is not an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Central Station
    ANNE View, Central Hub
    Hinscope
    Infinity Gateway Suite
    Biofourmis Everion+ (G2)
    Corsano CardioWatch 287-2 System
    Current Health System
    CNS-2101 Central Monitor
    Everion+ System
    Current Health System
    Infinity Gateway Suite
    eCareManager 4.5
    BeneVision Central Monitoring System
    Zyter RPM
    AirStrip ONE Web Client with Alarm Communication Management (ACM)
    AlertWatch:AC
    Current Health Monitoring System Gen 2 (G2)
    Aulisa Multiple Patient Digital Vital Sign Monitoring System
    Smart Alarm Interface
    Spire Health Remote Patient Monitoring System
    BeneVision Central Monitoring System
    Critical Alert CommonPath Enterprise
    Wearable Device, Wearable Package
    Philips IntelliVue XDS Software
    Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
    BeneVision Central Monitoring System
    Digistat Smart Central
    Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
    Unite Connect for Clinical Systems
    Athena GTX Device Management Suite (ADMS) Software
    eCareManager 4.1
    BeneVision Central Monitoring System
    eCareManager 4.0.1
    AirStrip RPM
    CareEvent inclusive of the CareEvent Mobile Application accessory
    Cerner CareAware Event Management
    EarlySense Central Display Station (CDS)
    Hypervisor IX Monitoring System
    VECTRAPLEX CMS
    CareEvent
    INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
    M3290B Philips IntelliVue Information Center iX
    HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
    ISIRONA MAGELLAN
    CLINICAL ALERT NOTIFICATION
    AIRSTRIP RPM FOR LIFENET CONSULT
    ZOLL RESCUENET 12-LEAD
    EARLYSENSE CENTRAL DISPLAY SYSTEM
    CONNEXALL SUITE OF SOFTWARE PRODUCTS
    M VISUM ALERT ALARM MANAGEMENT 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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