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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: KRA FDA class 2

    Catheter, Continuous Flush

    Cardiovascular

    View full classification →

    This device is a continuous flush catheter used in cardiovascular monitoring to maintain patency of arterial or central venous lines by delivering a slow, continuous infusion of heparinized saline, preventing clot formation and ensuring accurate pressure readings. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRA, regulated under 21 CFR 870.1210 within the Cardiovascular specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
    Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
    ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
    TriSalus TriNav® LV Infusion System
    Wallaby 017 Micro Catheter
    Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
    Maestro Microcatheter
    Vericor Support Catheter
    MAGIC Flow-Dependent Microcatheter
    Extroducer Infusion Catheter System
    PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
    Micro Catheter and Guidewire System
    Agile Devices Angler Steerable, Deflectable Microcatheter
    PROWLER SELECT PLUS; PROWLER EX
    Bullfrog Micro-Infusion Device
    SwiftNINJA Steerable Microcatheter
    Instylla Microcatheter 1.2
    Rebar Micro Catheter
    MAGIC Infusion Catheter
    Marathon Flow Directed Micro Catheter
    Fountain ValveTip Infusion Catheter
    ClariVein IC
    TRUSELECT Microcatheter
    Bendit2.7 Steerable Microcatheter
    Instylla Microcatheter
    Hereaeus Poseidon Microcatheter
    TriSalus Infusion System
    Instylla Microcatheter
    Multi-Sideport Catheter Infusion Set
    VAMP Plus Venous/Arterial Blood Management Protection System
    VAMP Optima closed blood sampling system
    VAMP Venous/Arterial Blood Management Protection System
    Microcatheter and guide-wire system
    CXI TriForce Peripheral Crossing Set
    Maestro Microcatheter
    Direxion and Direxion HI-FLO Torqueable Microcatheters
    FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
    VAMP Venous/Arterial Blood Management Protection System
    CXI Support Catheter
    SwiftNINJA Microcatheter
    Bullfrog Micro-Infusion Device
    CrossCath Support Catheter
    Bullfrog Micro-Infusion Device
    MMS Guide Catheter
    ClariVein IC
    Direxion Torqueable Microcatheter
    RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
    PEREGRINE SYSTEM INFUSION CATHETER
    CANTATA(R) 2.9 MICROCATHETER
    ND NABIL DIB INFUSION CATHETER

    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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