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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: DRG FDA class 2

    Transmitters And Receivers, Physiological Signal, Radiofrequency

    Cardiovascular

    View full classification →

    The Radiofrequency Physiological Signal Transmitter and Receiver is a cardiovascular telemetry device used to wirelessly transmit and receive physiological signals such as ECG or pressure data between a patient and monitoring equipment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRG and it is regulated under 21 CFR 870.2910 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TeleRehab Aermos Cardiopulmonary Rehabilitation
    iBSM
    UbiqVue™ 2A Multi-parameter System (UX2550)
    BioButton System
    ANNE Chest
    ANNE One
    HD+12, HD+15
    Alio
    Care Team Portal
    BioButton System
    ANNE Pediatric
    ers2 - ergoline Rehabilitation System
    EZYPRO ECG Recorder (Model: UG02)
    Alio Medical Remote Monitoring System
    LifePath Remote Patient Monitoring Platform
    ANNE One
    LifeSignals Multi-Parameter Remote Monitoring Platform
    LifeSignals ECG Remote Monitoring Patch Platform
    Vitls Platform
    Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
    Philips Biosensor BX100
    VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
    VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
    BioSticker System
    Life Sensor Cardiac Monitor
    VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
    VitalConnect Platform, VitalPatch Biosensor
    Surveyor S2
    Comarch e-Care Platform
    Caretaker Remote Display App and Caretaker Software Library
    LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
    ScioCardio ECG Transmitter
    BioStamp nPoint
    Patient Status Engine
    Rooti Rx ECG Event Recorder, Rooti Link APP Software
    VitalPatch® VitalConnect Platform
    Optum TeleHealth Application
    eCareCoordinator
    Ossler Exam Scope
    VitalWatch Software User Interface
    FFR Link, FFR Signal Processing Module
    TelePatch Cardiac Monitor
    LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
    Vital Connect Platform, HealthPatch MD, VitalPatch
    CARDIOLINE HD+
    SURVEYOR S4 MOBILE MONITOR
    GENESIS TOUCH SYSTEM
    LG SMARTHEALTH
    ECARE COORDINATOR (ECC)
    VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)

    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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