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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: FIE FDA class 2

    Needle, Fistula

    Gastroenterology, Urology

    View full classification →

    The Fistula Needle is a large-bore needle used to access an arteriovenous fistula or graft in patients undergoing hemodialysis, enabling connection to the dialysis circuit. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FIE, regulated under 21 CFR 876.5540, within the Gastroenterology, Urology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DORA Disposable A.V. Fistula Needle Sets
    Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
    DORA Disposable A.V. Fistula Needle Sets
    JMS Harmony A.V. Fistula Needle Set
    ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
    JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
    MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
    APLAN A.V. FISTULA NEEDLE SET
    JMS APHERESIS NEEDLE SET WINGEATER(R) V2
    WINGEATER V2
    SYSLOC MINI V3
    NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
    JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
    NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
    A.V. FISTULA BLUNT NEEDLE SET
    MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
    NIPRO BIOHOLE NEEDLE
    NIPRO SAFETOUCH II GAMMA
    SUPERCATH V
    JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
    PLUME SAFETY AVF NEEDLE
    FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
    SHARGHP A.V. FISTULA NEEDLE SET
    EXCEL A.V FISUTAL NEEDLE SET
    JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
    RENAX A.V. FISTULA NEEDLE SETS
    NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
    A.V. FISTULA NEEDLE
    MODIFICATION TO JMS APHERESIS NEEDLE
    MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
    MEDISYSTEMS BUTTONHOLE NEEDLE SETS
    BIOTEQUE A.V. FISTULA NEEDLE SET
    SHELLY PROTECTED AV FISTULA NEEDLE
    JMS A. V. FISTULA NEEDLE SET
    JMS APHERESIS NEEDLE
    NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
    JMS APHERESIS NEEDLE
    JMS AV FISTULA NEEDLE
    NIPRO ARTERIAL VENOUS FISTULA NEEDLE
    BRAUN DIACAN(R) FISTULA NEEDLES
    MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
    JMS APHERESIS NEEDLE
    VIVAMED FISTULA NEEDLE
    JMS AV FISTULA NEEDLES
    MEDISYSTEMS HEMODIALYSIS FISTULA SET
    NEEDLE, DIALYSIS
    EXEL A-V FISTULA SET
    ARTERIOVENOUS FISTULA SETS
    TERUMO AV FISTULA NEEDLE SET
    JMS APHERESIS NEEDLE

    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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