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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: DSI FDA class 2

    Detector And Alarm, Arrhythmia

    Cardiovascular

    View full classification →

    The Arrhythmia Detector and Alarm is a cardiovascular monitoring device that continuously analyzes the cardiac rhythm, identifies abnormal patterns indicative of arrhythmias, and alerts clinical staff through audible or visual alarms when a dangerous rhythm is detected. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSI and it is regulated under 21 CFR 870.1025 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Zio AT® device (A100A1001)
    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
    SmartCardia 7L Platform
    Unified Arrhythmia Diagnostic System PocketECG IV
    BodyGuardian Remote Monitoring System
    Patient Assistant Model PA97000
    Liba3 System
    MobileECG 2 BT
    Medicalgorithmics Unified Cardiac Rehabilitation System
    Epicardia Anywhere
    Braemar Telemetry Patch System
    EMMa Electronic Monitoring Management
    Matrix Mini ECG Monitor
    Nihon Kohden Afib Detection Program QP-039P
    Vital Signs Patch System
    ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
    MoMe Software Platform
    MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
    BodyGuardian Remote Monitoring System
    CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
    IntelliVue Patient Monitor
    Medtronic Patient Asistant
    IntelliVue Patient Monitor
    CardiacLinx
    MENNTOR X7
    VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
    TELESENSE
    CORCAM HEART MONITOR
    V-PATCH SYSTEM
    MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
    BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
    MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
    ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
    INTELLIVUE MX40 PATIENT MONITOR
    INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
    AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
    REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
    CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
    SPACELABS MULTI-PARAMETER MODULE
    MEDICAL MAGNETIC TAPE RECORDER
    MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
    CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
    VITALOGIK 6000/6500
    TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
    TELESENTRY, MODEL TS01
    INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
    AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
    MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
    EPICARDIA 5000
    AVIVO MOBILE PATIENT 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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