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510(k) Data Aggregation

    K Number
    K253149

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-13

    (141 days)

    Product Code
    Regulation Number
    884.5160
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253498

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-22

    (85 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 Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

    Device Description

    Pump In Style Pro+ is a powered breast pump intended to be used in a home environment (or similar such as an office). It features 2-Phase Expression technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm.
    Pump In Style Pro+ comprises a pump unit, which includes:

    • User-adjustable controls: "On/Off" for powering on/off the device, "Let-down" for switching between pumping phases, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
    • a port for connection of the tubing that channels the vacuum;
    • a port for connection of the power supply;
    • an internal, non-replaceable, rechargeable lithium-ion battery providing users the option to power the breast pump without reliance on a wall-connection or external power source;
    • a LED battery status indicator which informs users of available charge;
    • a pump phase LED status indicator which informs users of the active pump phase;
    • vacuum level LED indicators (total of 16, one for each vacuum level).
      Pump In Style Pro+ is a double electric breast pump that can be used to extract breast milk from one breast at a time (i.e., single pumping) or from both breasts simultaneously (i.e., double pumping). A DC (direct current) motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk.
      The materials of the milk-contacting components are compliant with 21 CFR 177 and 21 CFR 178.
    AI/ML Overview

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