BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

    K Number: K252672 · Decision Feb 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    2
    Review Days
    179

    Basic Information

    Device Name
    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
    K Number
    K252672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Casebioscience, Inc.
    Date Received
    August 25, 2025
    Decision Date
    February 20, 2026
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQL Media, Reproductive

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    Other Clearances by Casebioscience, Inc.

    K Number Device Name
    K242107 CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)