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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: MQX FDA class 2

    Needle, Acupuncture, Single Use

    General Hospital

    View full classification →

    The Single-Use Acupuncture Needle is a general hospital device consisting of a sterile, single-use fine needle used for the practice of acupuncture, in which needles are inserted at specific anatomical points to produce therapeutic effects. Classified as FDA Class 2 under 21 CFR 880.5580 in the General Hospital specialty, it is 510(k)-exempt and subject to general controls. The product code is MQX.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AIK Sterile Acupuncture Needles for Single Use
    Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
    EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
    KM Needles (Acupuncture Needle)
    SMC ACUPUNCTURE NEEDLE
    CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
    WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
    BIOMATE STERILE ACUPUNCTURE NEEDLE
    ACUPUNCTURE NEEDLES
    JIAJIAN ACUPUNCTURE NEEDLE
    HANSO ACUPUNCTURE NEEDLE
    TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
    BRIO ACUPUNCTURE NEEDLES
    PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
    LYRA ACUPUNCTURE NEEDLES
    ASP TITANIUM
    KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
    SEVEN STAR NEEDLE
    TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
    STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
    PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
    ACUPUNCTURE NEEDLES
    C&G ACUPUNCTURE NEEDLE
    ACUPUNCTURE NEEDLES
    PRESS TACK NEEDLE
    FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
    DBC PRESS ACUPUNCTURE NEEDLES
    NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
    SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
    VINCO BRAND ACUPUNCTURE NEEDLE
    CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
    TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
    JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
    MAEDA SILVER ACUPUNCTURE NEEDLE
    QIZHOU ACUPUNCTURE NEEDLE
    MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
    HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
    ACUGLIDE BRAND ACUPUNCTURE NEEDLES
    H.M.T. ACUPUNCTURE NEEDLE
    CW DISPOSABLE ACUPUNCTURE NEEDLE
    HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
    HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
    ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
    BW ACUPUNCTURE NEEDLES
    MAC ACUPUNCTURE NEEDLE
    MAEDA NEW NEEDLE DISPOSABLE
    HOLY DRAGON ACUPUNCTURE NEEDLES
    TAI-CHI ACUPUNCTURE NEEDLES
    TIANXIE
    SHENLING ACUPUNCTURE NEEDLES

    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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