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510(k) Data Aggregation

    K Number
    K251512

    Validate with FDA (Live)

    Device Name
    Hi bebe super (BT-150B)
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2025-09-25

    (132 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K200675
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hi bebe super (BT-150B) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

    Device Description

    The Hi bebesuper (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.

    BT-150B electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). BT-150B electrical breast pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.

    BT-150B electrical breast pump has three operating modes: massage mode, expression mode and program mode to save pressure level and cycle level and their mode (massage or expression) and their running time. Sixteen (16) vacuum pressure levels are available for operating mode ad massage mode. One cycle speed level is available for massage mode and three (3) cycle speed levels are available for expression mode. The device is capable of providing suction up to -270 mmHg.

    The subject device is a modified version of BT-150S model of K200675. Compared to the predicate device, the following changes are made.

    • Power source change. Both AC-powered mode and battery-powered mode are available.
    • Vacuum pressure and cycle speed.
    • User interface: Compared to the predicate device, the lamp button is removed, increase cycle speed button and decrease cycle speed button are combined as one cycle level change button, and the function of each button is modified.
    • Dual motors system: The subject device includes dual pumps while the predicate device includes a single pump. Compared to the predicate device, a sub board has been removed and both pumps are connected to the main board.
    AI/ML Overview

    N/A

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