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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: DPT FDA class 2

    Probe, Blood-Flow, Extravascular

    Cardiovascular

    View full classification →

    The Probe, Blood-Flow, Extravascular is a clinical device used to measure blood flow in vessels from outside the vessel wall, typically using Doppler or electromagnetic techniques during surgical procedures or diagnostic evaluations of vascular function. It is a Class 2 device requiring a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The product code is DPT, regulated under 21 CFR 870.2120, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Laser Speckle Imaging System (RFLSI CZW)
    SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
    moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
    Deltex Medical KDP72 Doppler Probe
    BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
    BIO-PROBE TRANSDUCER (ADULT)
    MOORLDLS-BI LASER DOPPLER BURNS IMAGER
    DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
    AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
    MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
    AIMAGO EASYLDI MICROCIRCULATION CAMERA
    PERICAM PSI
    I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
    MOORLD12-B1 LASER DOPPLER BURNS IMAGER
    MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
    MOORLDLS LASER DOPPLER LINE SCANNER
    DP240 240 HOUR DOPPLER PROBE
    MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
    JOSTRA FLOWPROBE FP-32E
    TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
    MOOORLDI LASER DOPPLER IMAGER
    ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
    VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
    TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
    LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
    TRANSTAR PRESSURE TRANSDUCER
    BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)
    K3 COMPUTER SYSTEMS
    TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
    FLOSCOPE MICRODOP
    SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
    KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
    HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
    TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
    APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
    ACCUCOM 2
    ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
    SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
    BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL
    HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
    PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
    A-V RECORDER
    SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
    INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
    MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
    BIO-PROBE SYSTEM-BLOOD FLOW PROBE
    P-2 ULTRASONIC ARTERIOGRAPH
    MASK, PXYGEN

    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

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