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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: JOM FDA class 2

    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

    Cardiovascular

    View full classification →

    The Plethysmograph, Photoelectric, Pneumatic or Hydraulic is a cardiovascular diagnostic instrument used to measure changes in blood volume or blood flow in peripheral vessels and limbs using photoelectric, pneumatic, or hydraulic sensing technologies, supporting assessment of peripheral vascular disease and circulatory disorders. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOM and is regulated under 21 CFR 870.2780, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PADnet Xpress
    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
    ASI Plethysmogrpah Analyzer
    Automated ankle brachial pressure index measuring device, MESI mTABLET system
    VitalScan ANS
    Automated ankle brachial pressure index measuring device
    TBL-ABI System
    TM-ABI system
    QuantaFlo
    BODYTRONIC 200
    DOPPLEX ABILITY
    PADNET 2.0
    MAX PULSE SYSTEM
    CRITICAL CARE ASSESSMENT
    FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
    ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
    SA-3000P
    PADNET+
    BIOMEDIX PADNET LAB
    MCPULSE
    A16 BLOOD FLOW MEASUREMENT SYSTEM
    PHLEBOTEST 2000
    PVR-100/VASOGRAM
    VENOMETER
    EC6 PLETHYSMOGRAPH
    VASOCOR PVR 100
    ELCAT D-PPG, PLETHYSMOGRAPH DEVICE
    A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER
    CWD/PPG MODULE
    MVL/MODULAB WITH PVR MODULE
    DOPCORD PPG
    VARITEST
    3D VASCULAR RECORDER
    PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
    TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
    PULSE CUFF RECORDER MODEL PCR100
    VASOPULSE(TM)/MODEL 5000
    OSM-1 OXYGEN SATURATION MONITOR
    NOVAMETRIX PULSE OXIMETER, MODEL 500
    DIGITMATIC DM2
    LIGHT REFLECTION RHEOGRAPHY
    PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
    MGI STRENGTH/FITNESS SYS-MODEL #PU-101
    HR 100T
    VASCULAB #VSC21
    EC-4 PLETHYSMOGRAPH
    HEART RATE COMPUTER STRIP CHART
    APOLLO HEART RATE INDICATOR
    NOVATEC PRM
    PLETHYSMOGRAPH, STRAIN GAUGE

    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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