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510(k) Data Aggregation

    K Number
    K260147

    Validate with FDA (Live)

    Device Name
    Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
    Manufacturer
    Shenzhen Kingboom Technology Co., Ltd.
    Date Cleared
    2026-03-13

    (52 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    2 - 12
    Reference & Predicate Devices
    K250697
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

    Device Description

    Electric nasal aspirator (model: BC026, BC025, BC023, BC028, BC029, BC036) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions.The motor pump is powered by a rechargeable battery. The rechargeable battery can be charged via an external power adapter(not included in this device) using the provided charging line. The user interface consists of buttons and LED display, and the user can control the air flow level through the button.

    The differences between BC026, BC025, BC023, BC028, BC029 and BC036 are as follows:

    1. The flow rate range of BC036 at different flow levels is different from other models.
    2. BC025 and BC036 do not have "Light" function(used to distract and pacify the child), while other models do.
    3. BC026, BC028, BC029 can pause suction during the suction process, while other models do not.
    4. BC026, BC028, BC029 and BC023 have 4 buttons, BC025 and BC036 have 2 buttons.
    5. In addition, BC026, BC028, BC029, BC025, BC036 and BC023 have different Display, Size, Weight, and Appearance.
    AI/ML Overview

    N/A

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