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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?
    Product Code :

    QOG

    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?
    Product Code :

    QOG

    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
    K241803
    Device Name
    INSULCLOCK® v2.0 PRO
    Manufacturer
    Insulcloud S.L.
    Date Cleared
    2024-08-22

    (62 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QOG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus. - Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision. - Insulclock® is designed for use in any home environment. - Using a compatible App. INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin dose-related data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
    Device Description
    The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature. Models: - INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®) - INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®)
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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?
    Product Code :

    QOG

    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?
    Product Code :

    QOG

    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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    K Number
    K212217
    Device Name
    Tempo Smart Button
    Manufacturer
    Eli Lilly and Company
    Date Cleared
    2022-09-16

    (427 days)

    Product Code
    QOG, OCN
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QOG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App). The Tempo Smart Button is indicated for single-patients 18 years or older who are: - . diagnosed with type 1 or type 2 diabetes mellitus, - using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev® - Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL], - using a compatible application (App).
    Device Description
    The Tempo Smart Button is a reusable data transmitter that detects and stores insulin doserelated data when attached to a disposable Tempo Pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology. The insulin dose-related data is used by the mobile application which can display the brand of insulin, dose amount, date, and time. Additionally, the Tempo Smart Button is available as part of a Welcome Kit. The Tempo Welcome Kit and Refill Kit provide the convenience of having a single kit that contains devices needed for insulin administration and blood glucose monitoring.
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