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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: LFJ FDA class 2

    Catheter, Subclavian

    Gastroenterology, Urology

    View full classification →

    A subclavian catheter is a vascular access device inserted through the subclavian vein to provide long-term intravenous access for the administration of fluids, medications, blood products, or parenteral nutrition, or for hemodynamic monitoring. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFJ and is regulated under 21 CFR 876.5540 within the Gastroenterology and Urology specialty. This device is flagged as an implant, as it is placed within the body for the duration of use.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MEDSURG INSERTION TRAY
    AKCESS0CATH KIT
    AKCESS-CATH
    ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
    SPLITTABLE SHEATH INTRODUCER SET
    COAXIAL ACUTE CATHETER
    VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
    HEMO-CATH SILICONE ACCESS CATHETER
    AKCESS-CATH KIT
    PERMANENT SILICONE CATHETERS
    MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
    SINGLE LUMEN CATHETER KITS
    SINGLE LUMEN CATHETERS, MODIFICATION
    DURACATH
    SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
    MODIFIED PERM-CATH
    DUALYSE-CATH - CODES #1132.212, 1132.112
    DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
    FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER
    ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
    HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
    DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
    DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
    SUBCLAVIAN HEMODIALYSIS CATHETER
    HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
    MODIFIED VAS-CATH CATHETER REPAIR KIT
    IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
    VAS-CATH CATHETER REPAIR KIT
    MEDSURG ACUTE DIALYSIS TRAY
    DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
    VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER
    MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
    LUER LOCK CONNECTORS / RIDIG P.V.C.
    PERMCATH INSERTION TRAY
    ADULT PERM-CATH 40CM.
    PERM-CATH CATHETER KIT
    VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH
    VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
    SINGLE LUMEN ACUTE CATHETER
    MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
    SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
    HURWITZ DIALYSIS CATHETER
    VACCESS TM 4006
    SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
    MNI 400 INJECTION CAPS
    VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
    VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
    VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH
    SINGLE LUMEN SUBCLAVIAN CANNULA
    DUAL LUMEN SUBCLAVIAN CANNULA

    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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