BEUDAMED
    Product Code: QJS FDA class 2 21 CFR 862.1356

    Interoperable Automated Glycemic Controller, Insulin Suspend

    Clinical Chemistry

    The Interoperable Automated Glycemic Controller, Insulin Suspend is a Class 2 Clinical Chemistry device that temporarily suspends and resumes insulin infusion from a connected infusion pump based on specified glucose thresholds, designed to reliably and securely communicate with digitally connected devices to maintain glycemic control. It requires 510(k) clearance and is regulated under 21 CFR 862.1356, reviewed by the Clinical Chemistry panel. The product code is QJS. The device is not an implant and is not flagged as life-sustaining.

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

    Basic Information

    Product Code
    QJS
    Device Class
    FDA class 2
    Regulation Number
    862.1356
    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 interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K193483 Basal-IQ Technology

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.