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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: MQF FDA class 2

    Catheter, Assisted Reproduction

    Obstetrics/Gynecology

    View full classification →

    The Assisted Reproduction Catheter is an obstetrics/gynecology device used in ART procedures such as embryo transfer or intrauterine insemination, designed for the gentle and precise delivery of gametes or embryos into the uterine cavity. Classified as FDA Class 2 under 21 CFR 884.6110, it requires 510(k) premarket notification. The product code is MQF, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
    FemaSeed Intratubal Insemination
    Daylily Single Use Sterile Embryo Transfer Catheter
    Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
    Kitazato ET Catheters
    Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
    Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
    Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
    Towako Transmyometrial Embryo Transfer Set
    Pivet and Soft-Pass Embryo Transfer Catheter Sets
    Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
    Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
    Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
    Soules Intrauterine Insemination Catheter
    Kitazato ET Catheters
    Kitazato IUI Catheter
    Transem and EchoGen Embryo Transfer Catheters
    CrossBay IVF Embryo Transfer Catheter Set
    MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
    FERTILIGENT SLOW RELEASE IUI CATHETER KIT
    KITAZATO IUI CATHETER
    IUI CATHETERS
    INTRAUTERINE INSEMINATION (IUI) CATHETER
    INTRAUTERINE INSEMINATION (IUI) CATHETER
    CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
    IUI CATHETER, MODEL 9057
    EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
    MORTON IUI CATHETERS
    WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
    COOPERSURGICAL MALLEABLE SYTLET
    COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
    TUCKER EMBRYO CATHETER
    COOPERSURGICAL TRIAL TRANSFER CATHETER
    COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
    IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
    EMTRAC; DELPHIN; SEMTRAC 2000 SET
    TAO EMBRYO TRANSFER CATHETER SYSTEM
    EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
    EMBRYON GIFT TRANSFER CATHETERS/SETS
    EMBRYON TRANSFER CATHETERS/SETS
    EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
    <GENX> EMBRYO TRANSFER CATHETER CC GLIDER
    WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
    WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
    WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
    INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
    TRANSMYOMETRIAL EMBRYO TRANSFER SET
    INTRATUBAL TRANSFER SETS
    GIFT CATHETER SET/S
    EMBRYO TRANSFER CATHETERS/SETS

    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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