BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AIO Breathe

    K Number: K252525 · Decision Nov 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    212
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    AIO Breathe
    K Number
    K252525
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aiomega, LLC
    Date Received
    August 11, 2025
    Decision Date
    November 6, 2025
    Product Code
    LRK
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRK Device, Anti-Snoring

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    Other Clearances by Aiomega, LLC

    K Number Device Name
    K233754 AIO Breathe