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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: DPS FDA class 2

    Electrocardiograph

    Cardiovascular

    View full classification →

    The Electrocardiograph is a diagnostic device used to record the electrical activity of the heart over time by placing electrodes on the skin, producing an electrocardiogram (ECG) used to detect cardiac arrhythmias, conduction abnormalities, and other cardiac conditions. It is a Class 2 device, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is DPS, regulated under 21 CFR 870.2340, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ZBPro Diagnostic
    Masimo W1
    CloudHRV™ System (100-01-001)
    Cardiac Workstation (5000); Cardiac Workstation (7000)
    Masimo W1
    DeepRhythm Platform
    MEDIBLU ECG SYSTEM
    Electrocardiograph, model: ECG301
    Impala
    CSF-4 (CSF-4)
    MCG-S (AM1000)
    Cardio Q50, Cardio Q70
    CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
    Masimo W1
    EKGenius Smart System
    Cardio P1
    Withings Scan Monitor 2.0
    MESI mTablet ECG Diagnostic System, MESI mTablet ECG
    Electrocardiograph: SE-1200 Pro and SE-1201 Pro
    AccurECG Analysis System
    CSF-3
    PageWriter TC35 Cardiograph
    Cardio10
    MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
    Coala Heart Monitor
    Electrocardiograph
    LE-12CH
    Cardiologs Holter Platform
    Scan Monitor
    electrocardiograph: SE-1202
    Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
    MAC 7 - Resting ECG Analysis System
    B-Secur HeartKey Software Library
    PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
    physIQ Heart Rhythm and Respiration Module
    AI-ECG Tracker
    CARDIOVIT AT-102 G2
    KardioScreen
    physIQ Heart Rhythm and Respiratory Module
    CardioFlux with Faraday Analytical Cloud
    ZOLL ECG Analysis Software
    COR12 ECG
    Cardio-TriTest v6.5
    CardioBand ECG Event Recorder
    MAC VU360 Resting ECG Analysis System
    Universal SmartECG
    physiQ Heart Rhythm Module
    CheckMyHeart Plus
    Kenz Cardico1211
    CardiMax Electrocardiograph

    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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