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510(k) Data Aggregation

    K Number
    K232608
    Device Name
    Duo Hands-free Breast Pump
    Manufacturer
    Medela LLC
    Date Cleared
    2024-04-12

    (228 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medela LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duo Hands-free breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Duo Hands-free breast pump is intended for a single user. The breast pump is intended to be used in a home environment.
    Device Description
    The Duo Hands-Free breast pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The device consists of the pump unit, two Hands-free Collection Cups (breast shields, membranes, outer shells), and tubing. The breast pump provides wireless connectivity via a Bluetooth Low Energy (BLE) 4.2 compliant protocol and is compatible with the Medela Family mobile application. The BLE component does not offer control of the breast pump and is only meant to store the information sent from the breast pump (such as session length, phases and vacuum intensity levels) and log additional information related to their pumping session. The device has four buttons allowing the user to power the device on/off, select between two pumping modes (expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The Duo Hands-free breast pump utilizes a microcontroller executing embedded software to interpret user inputs and modulate the voltage applied to a DC motor and a solenoid to produce a negative vacuum pressure applied to the user. The vacuum is generated by turning on the motor, incrementally drawing air out of the pump set on each rotation and expelling it into the atmosphere. When the cycle is complete, the solenoid valve is opened, relieving the vacuum. Vacuum generated by the breast pump unit is applied to the membrane in the Hands-free Collection Cup pump set causing it to displace away from the breast and to apply vacum to the breast. Vacuum applied to the breast will cause milk to be expressed and to accumulate on the milk valve. Once the vacuum is relieved by the solenoid valve, milk will fall through the milk valve into the outer shells, and the cycle is repeated. All milk contacting components are compliant with 21 CFR 174-179.
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    K Number
    K210759
    Device Name
    Solo, Swing Maxi
    Manufacturer
    Medela LLC
    Date Cleared
    2021-08-11

    (149 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medela LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts. The Solo™ / Swing Maxi™ breast pumps are intended for a single user. The breast pumps are intended to be used in a home environment.
    Device Description
    Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile. The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101). The Solo"M and Swing Maxi™ breast pumps feature 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. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features: - user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels; - a port for connection of the tubing that channels the vacuum for breast pumping; - a port for connection of the power supply; - a central LED light as status indicator; and - a textile lanyard as an interface to the user's clothes/body. The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression. Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.
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    K Number
    K200508
    Device Name
    Pump In Style
    Manufacturer
    Medela LLC
    Date Cleared
    2020-06-15

    (105 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medela LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pump In Style® is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This powered breast pump is intended for a single user and is intended to be used in a home environment.
    Device Description
    The Pump In Style® breast pump is used to express and collect milk from the breast of a lactating woman. The device is intended for daily use in a home environment to supplement breastleeding by a single user. Pumping can be performed on one breast (single pumping) or both breasts at the same time (double pumping). The Pump In Style® breast pump is comprised of the breast pump unit, connector (including membranes, connector body and cap), breast shields, tubing, collection bottles, and power adaptor. In addition, optional accessories such as carry bag, bottle stand, battery pack, cooler bag, cooling element, vehicle power adaptor and additional milk collection containers may be included in the packaging as part of the product offering. The Pump In Style® breast pump has user-adjustable controls for powering the device on/off, switching between two pumping modes, stimulation and expression, and controlling vacuum level within each of the modes. The Pump In Style® breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 140 cycles per minute. The tubing port is for connection of the tubing for pumping. The power supply port is for connection of the power supply or portable vehicle adaptor or battery pack. The Pump In Style® breast pump provides the following user features: - . 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: - o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing. - O Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently. - "Let-down" control to change between stimulation phase and expression phase. - The option of either single or double breast pumping. ●
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    K Number
    K181937
    Device Name
    Pump In Style Advanced, Advanced Personal Double Breastpump
    Manufacturer
    Medela LLC
    Date Cleared
    2018-10-16

    (89 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medela LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pump In Style® Advanced breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The powered breast pump is intended for a single user.
    Device Description
    The Pump In Style® Advanced breast pump and kit are used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Pump In Style® Advanced breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Pump In Style® Advanced breast pump employs a control knob (potentiometer) for the user to adjust the vacuum levels. Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute. The device employs a gear-driven diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge providing speed and directional control over the DC motor. The device is electrically powered from external batteries (AA batteries) or from an external direct plug-in AC power supply or from a vehicle lighter adapter. The device is provided non-sterile. The Pump In Style® Advanced breast pump provides the following user features: - . Rotary knob for user adjustment of vacuum level/cycles and on/off - 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ● - o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing - o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently. - . "Let-down" control to change between stimulation phase and expression phase. - Option of either single or double breast pumping. .
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