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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: FMI FDA class 2

    Needle, Hypodermic, Single Lumen

    General Hospital

    View full classification →

    The Single-Lumen Hypodermic Needle is a hollow needle with a single channel used to inject medications subcutaneously, intramuscularly, or intravenously, or to draw blood or other fluids. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMI, regulated under 21 CFR 880.5570 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Profoject™ Safety Pen Needles
    Verisafe Safety Sterile Needles (SSN)
    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
    PRESSONE™
    Safety Pen Needle
    Pen Needle
    Pen Injector Needle 32.5
    Profoject™ Disposable Needle
    Intraosseous Infusion Needles
    TSK SELECT™ Needle
    K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
    27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
    FROG (Filter Removal of Glass)
    K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
    SureFine Pen Needle
    Safety Winged Blood Collection Sets
    ACE Cannula
    Verifine® Pen Needles
    ZIEN IO Intraosseous Access System
    Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
    Sterile Hypodermic Needles for Single Use
    SteriCap Safety Needle; VitreJect Safety Needle
    MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®
    Insulin Pen Needle
    VitreJect® Needle; OcuSafe® Needle
    Sterile Safety Hypodermic Needles for Single Use
    Sterile Hypodermic Needles for Single Use
    Sterile syringes for single use with/without needle
    NovoFine® Plus
    Altaviz Needle Kit II
    EZ-IO Intraosseous Vascular Access System
    Pen Needle
    Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
    Disposable Insulin Pen Needle
    Shina Safety Needle
    Sterile Aesthetic Cannula and Hypodermic Needle
    Verisafe Safety sterile needles
    Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
    BD AutoShield Duo™ Pen Needle
    Sterile Hypodermic Needles for Single Use
    CCBIO ASCPO Needle
    Altaviz Needle Kit
    DropSafeTM SicuraTM
    Disposable Insulin Pen Needle
    Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
    IO Needle Safety Sheath
    Safety Insulin Pen Needles
    Sterile Hypodermic Needles for Single Use
    Sterile Safety Hypodermic Needles for Single Use
    Promisemed X-Safety Pen 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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