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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: FOZ FDA class 2

    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    General Hospital

    View full classification →

    The Short-Term Intravascular Therapeutic Catheter (less than 30 days) is a flexible tube inserted into a blood vessel for periods under 30 days to deliver fluids, medications, nutrition, or to perform hemodynamic monitoring. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FOZ, regulated under 21 CFR 880.5200 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BD Cathena™ Safety IV Catheter
    BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
    BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    Ruby Intravascular Catheter
    OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
    HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
    Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
    Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
    SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
    PowerGlide Pro™ Midline Catheter
    Introcan Safety® 2 IV Catheter
    AccuCath Ace™ Intravascular Catheter
    Nouvo Safety Set
    BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    Nexiva™ Closed IV Catheter System with NearPort™ IV Access
    Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
    OSPREY Closed IV Catheter System (OspreyV2)
    Mais Central Venous Catheter
    Polyguard and Polyshield Safety IV Catheters
    OSPREY PERIPHERAL IV Catheter System
    Cook® Spectrum® 2 MRC Central Venous Catheter
    HydroMID 4F Single Lumen Midline Catheter
    MagiCath II
    Leaderflex Mini and Leaderflex Nano
    Introcan Safety 2 IV Catheter
    Introcan Safety IV Catheter
    BD Cathena Safety IV Catheter
    Pluski Safe 1 Safety IV Catheter
    B. Braun Introcan Safety 2 IV Catheter
    Introcan Safety 3 Closed IV Catheter
    Disposable IV catheter
    BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
    HydroMID
    BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
    ACENT™ Central Venous Catheter
    BD Cathena Safety IV Catheter
    Deltaven Fast Flash Closed I.V. Catheter Systems
    MedSource CathMED IV Catheter
    MF SAFECATH
    BD Centro Vena Acute Central Line (7 French Dual Lumen)
    Introcan Safety 2 IV Catheter 18-24 gauge
    Health Line CT Midline Catheter
    BD Cathena (TM) Safety IV Catheter
    Health Line CT CVC
    BD Acute Central Line
    Supercath 5
    AccuCath Ace Intravascular Catheter
    Cook Unimpregnated Central Venous Catheter
    BD Nexiva Closed IV Catheter System

    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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