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

    The Circadia C300 System (C300)

    K Number: K261286 · Decision May 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    The Circadia C300 System (C300)
    K Number
    K261286
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circadia Health, Inc.
    Date Received
    April 20, 2026
    Decision Date
    May 20, 2026
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Circadia Health, Inc.

    K Number Device Name
    K252676 The Circadia C300 System (C300)