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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: DSK FDA class 2

    Computer, Blood-Pressure

    Cardiovascular

    View full classification →

    The Blood-Pressure Computer is a cardiovascular computing device used to calculate, process, and display blood pressure values and related hemodynamic parameters from pressure transducer signals during patient 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 DSK and it is regulated under 21 CFR 870.1110 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Endophys Blood Pressure Monitor model BPM-30
    Endophys Blood Pressure Monitor
    CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
    ENDOPHYS BLOOD PRESSURE MONITOR
    MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
    SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
    MONITORING SYSTEM, MODEL ARGUS PB-2200
    ABP FOR WINDOWS
    RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
    ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
    SMARTFLOW, MODEL SFIP 2000
    SPHYGMOCOR MX MODEL SCOR-MX
    RADIANALYZER, MODEL 12710
    INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
    VITALMAX 4000/MINIPACK 3100/3000
    AS/3 PRESSURE TEMPERATURE MODULE, M-PT
    BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
    AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
    A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
    PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
    CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
    SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
    XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
    MEDILOG OPTIMA
    MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
    TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
    VITAL SIGNS MONITOR
    SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
    CARDIOCAP(TM) CMO-104 MONITOR
    PROPAQ 104(TM)
    TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
    TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
    TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
    FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
    MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
    MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
    SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
    FORTEC MI-100, BLOOD PRESSURE METER
    MODIFIED CARDIOCAP MONITOR
    PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
    SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
    HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
    POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
    POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
    LME BLOOD PRESSURE MONITOR
    DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN
    HTS *1
    MODEL 78553A PRESSURE PLUG-IN MODULE
    VITA-STAT MODEL 9000-S
    VITA-STAT MODEL 9000-A

    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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