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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: MQK FDA class 2

    Labware, Assisted Reproduction

    Obstetrics/Gynecology

    View full classification →

    Labware for Assisted Reproduction encompasses obstetrics/gynecology devices such as dishes, plates, tubes, and containers specifically designed and manufactured for use in ART laboratories to culture and handle gametes and embryos. Classified as FDA Class 2 under 21 CFR 884.6160, this labware requires 510(k) premarket notification. The product code is MQK, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SperSort™ Sperm Sorting Chip (IPG02)
    Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
    cryo-GO Vitrification Device
    G-Vitri™ Vitrification Straw
    SpermAlign Sperm Separation Device
    Nest VT Vitrification Device
    LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
    EmbryoSlide+ ic8 dish
    SureStrip Vitrification Straw, SureLock Vitrification Straw
    Pasteur Pipette 3mL, Pasteur Pipette 1mL
    VitriGuard
    Rapid-i™ Kit
    Cryotop®US-flash and Cryotop®US-scoop
    VitriGuard
    ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
    iVitri Straw
    iVitri EZ
    VitriGuard
    Cryotec
    Cryotop US
    EmbryoSlide Culture Dish
    Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
    RAPID-I KIT
    EEVA DISH (WITH 12 MICROWELLS)
    QUALIS
    CRYOTOP(R) SC
    PROINSERT
    CRYOLOCK
    CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
    SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
    CRYOTOP
    RI MSC (MIGRATION SEDIMENTATION CHAMBER)
    EEVATM PETRI DISH
    CRYOPETTE
    HSV STRAW
    RAPID-I
    NUNC IVF CENTERWELL AND ICSI DISHES
    BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
    SUNIVF DISHES
    NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
    PICSI SPERM SELECTION DEVICE
    NUNC IVF MULTIDISH 4 WELLS NUNCLON
    PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
    ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
    GENX CULTURE DISH
    NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
    FALCON IVF ROUND DISH
    FALCON IVF ONE WELL DISH
    FALCON IVF FOUR WELL PLATE

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump