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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: MQE FDA class 2

    Needle, Assisted Reproduction

    Obstetrics/Gynecology

    View full classification →

    The Assisted Reproduction Needle is an obstetrics/gynecology device used in assisted reproductive technology (ART) procedures such as oocyte retrieval or intracytoplasmic sperm injection (ICSI), designed for precise puncture and aspiration or injection in reproductive medicine settings. Classified as FDA Class 2 under 21 CFR 884.6100, it requires 510(k) premarket notification. The product code is MQE, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    32 matches
    K Number
    Device Name
    VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
    Wallace Dual Lumen Oocyte Recovery System
    Wallace Dual Lumen Oocyte Recovery System
    Single Lumen Ovum Aspiration Needles
    Double Lumen Ovum Aspiration Needles
    Follicle Aspiration Set, Reduced Single Lumen
    Kitazato OPU Needles
    Follicle Aspiration Set
    OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
    KITAZATO OPU NEEDLE
    FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
    OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
    MONA LISA ASPIRATION NEEDLE
    EMBRYON ULTRASOUND NEEDLE GUIDE
    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
    COOPERSURGICAL OOCYTE RECOVERY NEEDLES
    FAS SET #4551
    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
    OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
    EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
    WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
    OOCYTE ASPIRATION NEEDLE
    OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
    OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
    <GENX> DOUBLE LUMEN NEEDLE
    <GENX> SINGLE LUMEN SIDEPORT NEEDLE
    <GEN>SINGLE LUMEN NEEDLE
    SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
    HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
    OVUM PICK-UP ASPIRATION 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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