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510(k) Data Aggregation

    K Number
    K252342

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (144 days)

    Product Code
    Regulation Number
    884.5160
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric Breast Pump (Model YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

    Device Description

    The Electric Breast Pump (Models YM-8807, YM-8805, YM-8806 and YM-8810) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is provided non-sterile and is reusable device intended for a single user in home healthcare environment.

    The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The motor unit operates on a rechargeable Lithium battery (3.7V/1400mAh). The rechargeable battery can be charged from the external power adaptor specified in the User Manual (not included) through the provided USB charging cable. The user interface features four buttons (power, mode selection, vacuum level increase and decrease) and an LED display (current mode, level, timer and battery status), allowing the user to navigate between modes and adjust the vacuum pressure.

    The subject device includes four models that have same working principle and technology but differ in terms of their appearance, components, and materials. All device models have three modes of operation: Stimulation phase, Expression phase, Simulated sucking Phase, with nine levels in each mode. The Stimulation phase provides high cycle frequency and gentle suction, while the Expression phase provided slower cycles with higher vacuum pressures. The Simulated sucking phase provides a combination of the other two phases - two cycles in Expression phase followed by one Stimulation phase cycle, then three Expressions phase cycles followed by two in Stimulation phase to form one cycle.

    To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

    AI/ML Overview

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