BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Earflo (EF001)

    K Number: K252751 · Decision Feb 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    165

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    Basic Information

    Device Name
    Earflo (EF001)
    K Number
    K252751
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Earflo, Inc.
    Date Received
    August 29, 2025
    Decision Date
    February 10, 2026
    Product Code
    MJV
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MJV Device, Inflation, Middle Ear

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