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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: DSH FDA class 2

    Recorder, Magnetic Tape, Medical

    Cardiovascular

    View full classification →

    The Medical Magnetic Tape Recorder is a cardiovascular data recording device used to store physiological signals such as ECG or hemodynamic waveforms on magnetic tape for later playback and analysis, such as in ambulatory Holter monitoring. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSH and it is regulated under 21 CFR 870.2800 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AeviceMD
    AT-Patch (ATP-C130/ATP-C70)
    HiCardi+ H100
    S-Patch (S-Patch ExL)
    ABPMpro
    Carnation Ambulatory Monitor
    Holter ECG and ABP System
    S-Patch Ex Wearable ECG Patch
    AeviceMD
    CardioSTAT® ECG Test Solution
    eWave Monitor
    AT-Patch ECG Analysis System
    QOCA Portable ECG Monitoring Device
    Strados Remote Electronic Stethoscope Platform (RESP)
    LifeLens Wireless ECG Monitor
    Zio Monitor
    QardioCore
    Carnation Ambulatory Monitor (CAM)
    M5 Recorder
    Strados Remote Electronic Stethoscope Platform (RESP)
    Bioflux Software II
    Carnation Ambulatory Monitor
    Carnation Ambulatory Monitor
    Carnation Ambulatory Monitor
    Carnation Ambulatory Monitor
    ECG recorder and Arrhythmia Detector
    Portable ECG Monitor (ECG3)
    ePatch
    Peerbridge Cor(TM) System
    Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
    my Patch sl
    Bioflux Software
    myPatch-s
    Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
    ZIO SR ECG Monitoring Service
    Carnation Ambulatory Monitor
    MYPATCH
    STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
    ZIO PATCH
    ZIO PATCH
    MYSENSE HEART
    VITALOGRAPH MODEL 7100 - VITALOJAK
    GLOBALCARDIO
    KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
    VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
    VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
    PULMOTRACK 5050 WHOLTER, MODEL 5050
    COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
    COR12+
    ZIO PATCH, MODEL Z100

    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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