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

    Community Containers (Flap and Daisy)

    K Number: K252637 · Decision Oct 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    1
    Review Days
    55

    Basic Information

    Device Name
    Community Containers (Flap and Daisy)
    K Number
    K252637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keter Canada, Inc.
    Date Received
    August 20, 2025
    Decision Date
    October 14, 2025
    Product Code
    MMK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MMK Container, Sharps

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