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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: DRT FDA class 2

    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    Cardiovascular

    View full classification →

    The Cardiac Monitor (including Cardiotachometer and Rate Alarm) is a cardiovascular monitoring device used to continuously observe and display the heart's electrical activity, calculate heart rate, and trigger alarms when the rate falls outside set limits, thereby supporting patient safety in clinical settings. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRT and it is regulated under 21 CFR 870.2300 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    The Circadia C200 System
    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
    Neteera 130H-Plus Vital Sign Monitoring Sensor
    Sleepiz One+
    Neteera 130H/131H Vital Sign Monitoring Sensor
    Cardiac Trigger Monitor
    Vital Sign Monitoring Sensor (Model :XK300)
    Philips wearable biosensor-G5 Solution
    Vios Monitoring System™ Model 2050
    Cardiac Trigger Monitor
    Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
    Vios Monitoring System
    ESA615
    ESA620 ELECTRICAL SAFETY ANALYZER
    PROSIM 4, PROSIM 6, PROSIM 8
    CARDIAC TRIGGER MONITOR
    MPS450 MULTIPARAMETER SIMULATOR
    HRV ACQUIRE
    ZOLL PROPAQ M
    LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
    LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
    UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
    506CN PATIENT MONITOR
    LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
    CARDIAC TRIGGER, MODEL: CTM300
    PAM 3000
    LIFEBED PATIENT VIGILANCE SYSTEM
    PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
    12 RL ALGORITHM
    LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
    506 PATIENT MONITOR
    TRIFIT 700
    TRANSMITTER, ZS-940PA SERIES
    MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
    PM-8000 PATIENT MONITOR, MODEL 8000
    ENVAN HEART RATE MONITOR
    PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
    507EL VITAL SIGNS MONITOR
    MICROPAQ, MODELS 402, 404
    SIEMENS INFINITY SC 6002XL MODIFICATIONS
    SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
    PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
    ACTIVEECG
    A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
    ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
    MICROPAQ, MODELS 402 AND 404
    ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
    ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
    ATLAS MONITOR
    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

    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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