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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: MWI FDA class 2

    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    Cardiovascular

    View full classification →

    A Physiological Patient Monitor Without Arrhythmia Detection or Alarms is a device that continuously measures and displays one or more physiological parameters (such as heart rate, blood pressure, or respiration) without automated arrhythmia recognition or alarm capabilities, used for basic patient surveillance in lower-acuity settings. It is FDA Class 2, requiring 510(k) clearance, with product code MWI under 21 CFR 870.2300 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    WARD-CSS (v1.2.x)
    iCare APP
    Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
    Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
    AMC Health CareConsole
    Happy Ring Health Monitoring System
    WVSM Pro (Series) (500-0030-XX)
    NeoBeat, NeoBeat Mini
    Portrait VSM
    Talis EMR with Talis +ACG (Talis EMR with +ACG)
    Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O
    Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
    CPM System
    Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    Change Healthcare Cardiology Hemodynamics™
    Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™
    ARC Intensive Care Information System (ARC System)
    Huma RPM (RPM)
    The Heart Seat
    Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
    VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
    Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
    Welch Allyn Connex Central Station
    MedWand
    Capsule Surveillance System
    Vital Signs Monitor
    Capsule Vitals Plus Patient Monitoring System
    Vital Signs Monitors
    Philips MR Patient Care Portal
    Vitals360 Multi-Vitals Mobile Monitor
    ZOLL Propaq M
    740 SafeSAT
    MouthLab Vital Signs Monitoring System
    Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
    T3 Platform software
    Masimo Rad-97 Pulse CO-Oximeter and Accessories
    SmartLinx Vitals Plus Patient Monitoring System
    Oxi-W System
    Masimo Centroid System
    Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
    WVSM (Wireless Vital Signs Monitor) RWC + miniCap
    Eko Analysis Software
    Masimo Rad-97 and Accessories
    T3 Platform software
    LifeWindow LW8 Lite
    PeraMobile and PeraWatch
    B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
    DynoSense Vital Sign Measuring System
    Nihon Kohden SVM-7200 Series Vital Signs 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.

    Popular Product Codes

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