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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: LJT FDA class 2

    Port & Catheter, Implanted, Subcutaneous, Intravascular

    General Hospital

    View full classification →

    Port and Catheter, Implanted, Subcutaneous, Intravascular is a totally implantable vascular access system consisting of a subcutaneous port connected to an intravascular catheter, used to provide repeated long-term access to the bloodstream for administration of medications, fluids, blood products, or parenteral nutrition. It is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJT, regulated under 21 CFR 880.5965, within the General Hospital medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port
    PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
    PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port
    SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
    Bard Power-Injectable Implantable Ports (PowerPorts®)
    NMI DUAL PORT II
    BardPort®, SlimPort®, and X-Port® Implanted Ports
    Dignity Dual Port
    NMI Port, NMI Port II
    Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
    Vital-Port Vascular Access System Power Injectable Port
    INVISIPORT
    VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
    POWERPORT IMPLANTABLE PORT
    MEDCOMP GEN III POWER INJECTABLE PORT
    POLYSITE IMPLANTABLE INFUSION PORTS
    NMI PORT II CATHETER
    5F DIGNITY CT TITANIUM PORT
    LPP (LOW PROFILE PORT)
    NMI PORT
    CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
    POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
    DIGNITY POWER INJECTABLE TITANIUM PORT
    DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
    NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
    INVISIPORT
    NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
    NORFOLK MEDICAL NORPORT FAMILY OF PORTS
    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
    PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
    C-PORT - HP POWER INJECTABLE PORT
    POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
    RHAPSODY MRI
    RHAPSODY CT
    COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
    SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
    POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
    STD MED PRIMO PORT POLY
    JET PORT PLUS HP CATHETER SYSTEM
    MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
    POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
    MODIFICATION TO: T-PORT HP INFUSION PORT
    TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
    TITANIUM POWERPORT ISP IMPLANTED PORT
    T-PORT HP INFUSION PORT
    STD MED PRIMO PORT
    POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE
    POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
    VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
    POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX 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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