BEUDAMED
    Product Code: QDK FDA class 2 21 CFR 862.1355

    Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

    Clinical Chemistry

    The Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia, while also aiding in detecting hyperglycemia and hypoglycemia and autonomously communicating with digitally connected devices for diabetes management. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 862.1355 in the Clinical Chemistry specialty. The product code is QDK. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    3

    Basic Information

    Product Code
    QDK
    Device Class
    FDA class 2
    Regulation Number
    862.1355
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K203089 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
    K193642 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
    K192787 Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
    K182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.