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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: MQL FDA class 2

    Media, Reproductive

    Obstetrics/Gynecology

    View full classification →

    Reproductive Media are obstetrics/gynecology devices consisting of specialized culture media formulations used to maintain and support the viability, development, and growth of gametes and embryos during ART procedures. Classified as FDA Class 2 under 21 CFR 884.6180, they require 510(k) premarket notification. The product code is MQL.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ultra-Fast Warm
    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
    Fast Warm - NX
    Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
    Ultra-Fast Vitri; Ultra-Fast Warm
    FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
    Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
    Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
    V-GRAD
    CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
    Sperm Freezing Medium
    ARTSMedia Semen Wash Medium
    ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
    Giftlife® Single-Step Medium Plus
    V-VITFREEZE and V-VITWARM
    Vitrification Solution Set and Warming Solution Set
    Ultra RapidWarm™ Blast
    Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
    Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
    Oocyte Flushing & Retrieval Medium; Gamete Buffer
    SSS-NX (Serum Substitute Supplement-NX)
    V-PVP
    G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media
    Dewin Blastocyst Medium (with HSA and without HSA)
    V-HYADASE
    CryoX Vitrification Freeze Kit / Thaw Kit
    ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
    V-SPERM WASH
    V-HEPES PLUS
    Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
    VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
    Gx-IVF, Gx-TL, Gx-MOPS PLUS
    V-ONESTEP
    GM501 Wash with Phenol Red and Gentamicin
    Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
    VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
    iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
    Sperm Freeze, Sperm Fridge
    Synvitro Hyadase
    GM501 SpermAir and GM501 SpermActive
    SepaSperm Washing Solution, SepaSperm Solution
    GM501 Mineral Oil
    GM501 Wash
    1-Step Culture Medium
    RapidVit™ Oocyte, RapidWarm™ Oocyte
    Vit Kit- Freeze NX and Vit Kit- Warm NX
    Cumulus Remover
    Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
    SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
    ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)

    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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