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510(k) Data Aggregation

    K Number
    K251500
    Device Name
    MallyaG Injection Pen Adapter (MallyaG)
    Manufacturer
    Biocorp Production
    Date Cleared
    2025-06-09

    (25 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biocorp Production

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are: - Sogroya (somapacitan-beco) - Norditropin FlexPro
    Device Description
    The MallyaG Injection Pen Adapter is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the MallyaG device, is also provided in the package. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected.
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    K Number
    K250555
    Device Name
    MallyaD injection pen adapter (MallyaD)
    Manufacturer
    BioCorp Production
    Date Cleared
    2025-03-27

    (30 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioCorp Production

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MallyaD Injection Pen Adapter is indicated for the capture and wireless transmission of compatible reusable and disposable pen injectors. The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are: - insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch) - insulin aspart molecule (Fiasp FlexTouch) - insulin degludec and liraglutide molecules (Xultophy)
    Device Description
    The concerned Mallya Injection Pen Adapter, also called Mallyaº, is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the Mallya® device is also provided in the package.
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    K Number
    K231820
    Device Name
    SoloSmart Injection Pen Adapter (SoloSmart®)
    Manufacturer
    Biocorp Production
    Date Cleared
    2024-01-12

    (205 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biocorp Production

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
    Device Description
    The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.
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    K Number
    K222689
    Device Name
    Mallya Injection Pen Adapter (Mallya® for Solostar®)
    Manufacturer
    Biocorp Production
    Date Cleared
    2022-12-05

    (90 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biocorp Production

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
    Device Description
    The device is made of two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.
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