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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: MHX FDA class 2

    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    Cardiovascular

    View full classification →

    The Patient Physiological Monitor with Arrhythmia Detection or Alarms is a device that continuously measures and displays one or more physiological parameters such as heart rate, blood pressure, or oxygen saturation, and includes automated detection algorithms or alert systems to notify clinicians of cardiac arrhythmias or other abnormal conditions. It is classified as a Class 2 device under 21 CFR 870.1025, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, and is overseen by the Cardiovascular specialty panel. It is subject to general and special controls and does not carry implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Radius VSM and Accessories
    M12 Telemetry System
    ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
    Vista CMS
    uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
    Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
    IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
    Corvair Monza
    Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
    IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
    IntelliVue Patient monitors MX400, MX450, MX500, MX550
    IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
    Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
    Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
    Radius VSM and Accessories
    Telemetry Monitor 5500 Release 4.0 (867232)
    Infinity CentralStation Wide
    Patient Monitor (RespArray)
    Corvair
    Patient Monitor (iX10, iX12, iX15)
    Central Monitoring System (MFM-CMS)
    IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
    IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
    Infinity CentralStation Wide, Infinity M300, Infinity M300+
    IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
    ARGUS PB-3000
    Radius VSM and Accessories
    CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
    IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
    Multi-Parameter Patient Monitor
    Mural Clinical Viewer
    EK12 V2 Algorithm
    Patient Monitor: RespArray
    Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
    Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
    Next Generation NetKonnect
    N Series Patient Monitors
    CARESCAPE B650, E-musb
    CARESCAPE B450, E-musb
    Carescape B850, E-musb
    CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
    Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
    Patient Information Center iX
    Infinity Acute Care System (IACS) Monitoring System
    Infinity Acute Care System (IACS) Monitoring Solution
    IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
    Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
    Patient Monitor
    BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
    Monitor B125, Monitor B105

    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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