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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: LJS FDA class 2

    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    General Hospital

    View full classification →

    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days is a catheter designed for placement within the vascular system for extended therapeutic use exceeding 30 days, such as for prolonged intravenous medication administration, chemotherapy, or parenteral nutrition. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJS, regulated under 21 CFR 880.5970, within the General Hospital medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
    PM2+ System and SmartPICC Stylet
    pilot TLS
    Neonav ECG Tip Location System
    HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)
    PM2 System and ECGuide Connector
    CATHTONG III Tapered PICC Catheter
    L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
    CATHTONG™ II PICC Catheter
    CATHTONG™ II PICC Catheter
    Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
    VPS Rhythm DLX Device with TipTracker Technology
    HydroPICC 5F Dual Lumen Catheter
    BD PowerPiCC Catheter
    Groshong NXT PICC Catheter
    Piccolo Medical SmartPICC System
    Biowy PICC Catheter S Kit
    HydroPICC (PICC-142)
    Jet Power Injectable PICC
    5 FR Dual Lumen Piper PICC
    Sherlock 3CG+ T ip Confirmation System
    Biowy PlCC Catheter
    3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
    Hickman TriFusion Catheter
    C3 Wave System
    Vygon PICCs
    Silicone Peripherally Inserted Central Venous Catheter Set/Tray
    HydroPICC
    C3 Wave System
    Celerity ECG Cable Accessory Pack
    Sherlock 3CG Tip Positioning System Stylet
    CATHTONG II PICC Catheter
    CATHTONG II PICC Catheter
    PowerPICC Provena Catheters with SOLO Valve Technology
    PICC Maximal Barrier Nursing Kit
    VPS Rhythm Device with TipTracker Technology
    PowerPICC Provena Catheters
    Turbo-Flo PICC Sets
    CG+ Arrow JACC
    Cathtong I PICC Catheter
    PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
    Amecath Peripheral inserted Central Venous Catheter Sets
    CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
    CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
    PICC Tip Positioning Aid
    Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
    C3 Wave
    Xcela Power Injectable PICC
    NMI PICC III and NMI PICC IV
    NAUTILUS DELTA

    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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