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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: DSB FDA class 2

    Plethysmograph, Impedance

    Cardiovascular

    View full classification →

    The Impedance Plethysmograph is a cardiovascular diagnostic device used to measure changes in blood volume within a body segment by detecting variations in electrical impedance, helping assess venous thrombosis, arterial occlusion, or cardiac output. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSB and it is regulated under 21 CFR 870.2770 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SOZO Pro
    Zynex Monitoring System, Model CM-1600
    Bodyport Cardiac Scale
    SOZO
    SOZO Body Fluid Analyzer
    Cardiac Monitor 1500
    ReDS System
    Cardiovascular Analzyer
    SOZO
    ECOM™ Cardiac Output Monitoring System
    ReDs Wearable System
    IMED-Z FLUID STATUS MONITOR
    PHYSIOFLOW Q-LINK
    ZOE FLUID STATUS MONITOR
    ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
    ZOE FLUID STATUS MONITOR
    ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
    BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
    CHEETAH RELIANT
    PHYSIOFLOW ENDURO
    BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
    CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
    CHEETAH RELIANT
    ICON, MODEL C3
    AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
    PHYSIOFLOW SYSTEM
    AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
    CHEETAH RELIANT, CHEETAH ACTIVE
    BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
    BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
    BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
    BIOZDX HEMODYNAMIC MONITOR
    ZOE FLUID STATUS MONITOR
    C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
    ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
    ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
    TASK FORCE MONITOR 3040
    SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
    MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
    BIOZTECT SENSOR AND BIOZTECT CABLE
    ICG MODULE
    BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
    BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
    IQ SYSTEM
    BIOZ.COM SYSTEM
    PERCUPUMP II WITH EDA
    EDEMA SYSTEM
    BIOZ SYSTEM & BIOZ PORTABLE
    HOTMAN
    D SERIES ELECTRODE

    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.

    Popular Product Codes

    Commonly searched
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