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510(k) Data Aggregation

    K Number
    K230590
    Device Name
    ARDO Bellis
    Manufacturer
    ARDO Medical AG
    Date Cleared
    2023-03-30

    (27 days)

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

    ARDO Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
    Device Description
    The Ardo Bellis is a breast pump unit for collecting breast milk by application of a defined vacuum with a defined frequency on a woman's breast. The pump needs to be connected to a single or double pump set (Carum and Calypso Powered Breast Pumps, cleared under K141742) to be used on one or two breasts. The case and controls of the pump unit have limited contact with the user and are intended only to control the activities of the device parts that contact the user's breast. The device is comprised of an ON/OFF button and two +/- buttons for adjusting (increasing or decreasing) the vacuum and cycle speed. The pump can also be operated using the accompanying mobile application. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. An integrated battery allows for portable use of the device. With the supplied power adapter, the device can be recharged. Ardo Bellis can be used indoors in professional as well as home care environments.
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    K Number
    K212773
    Device Name
    ARDO Alyssa
    Manufacturer
    ARDO Medical AG
    Date Cleared
    2022-04-15

    (227 days)

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

    ARDO Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user.
    Device Description
    The Ardo Alyssa is a powered breast pump that generates negative pressure to express millt from the breasts of lactating women. It is intended for a single user and can be used in professional healthcare and home environments. The pump can be used for single or double breast pumping. To operate as a single or double pumping system, the pump needs to be connected to a single or double pump sets to be provided with the Ardo Alyssa are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump. The Ardo Alyssa has two operational modes (stimulation and expression), with eight vacuum levels in each mode. The device comprises an ON/OFF button and two +/- buttons for independently adjusting (increasing or decreasing) vacuum and cycle. The user also has an option to operate the device via the mobile app, MyArdoApp. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. The pump can be powered using the supplied power adapter or by an integrated rechargeable battery.
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    K Number
    K172067
    Device Name
    One Mum Pumpset
    Manufacturer
    Ardo medical AG
    Date Cleared
    2017-11-29

    (145 days)

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

    Ardo medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
    Device Description
    The One Mum Pumpset is a sterile pumpset accessory used by a single user in conjunction with the Ardo breastpumps. The Pumpset has nearly identical technological characteristics and identical principles of operation as the non-sterile pumpset previously cleared in the Ardo Carum and Calypso Powered Breast Pumps (K141742), with the minor difference being that the Pumpset is sterilized using an ethylene oxide gas cycle. Like the predicate device non-sterile pumpset, the One Mum Pumpset consists of multiple components including a bottle, bottle cap, polypropylene breast shell, and silicon tubing kit that connects to the breast pump for the removal, collection, and storage of the mother's breast milk. The Pumpset can be used both as a single pumpset and as a double pumpset and may be used in indoor settings including hospital and home.
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    K Number
    K150721
    Device Name
    ARDO Calypso Pro Powered Breast Pump
    Manufacturer
    ARDO MEDICAL AG
    Date Cleared
    2015-06-17

    (90 days)

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

    ARDO MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
    Device Description
    The ARDO Calypso Pro Powered Breast Pump is a single piston pump for hospital, rental and personal use. The unit is equipped with a robust plastic housing and a simplified, logically-organized keyboard with an LCD display readout. The electrical equipment is designed for outlet and for car battery-operation, or for (optional) battery use. The controls allow each mother to customize the settings through a flexible system for adjusting vacuum and cycles. The ARDO Calypso Pro breast pump's vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting.
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    K Number
    K141742
    Device Name
    ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
    Manufacturer
    ARDO MEDICAL AG
    Date Cleared
    2014-10-17

    (112 days)

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

    ARDO MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users. The ARDO Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The ARDO Pumpset should be used in combination with ARDO breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset.
    Device Description
    ARDO Carum and Calypso Powered Breast Pumps consist of the breast milk pump and a pump set (single or double pump set). They are double piston or reciprocating pumps for hospital, rental and personal use. The units are equipped with a robust plastic housing and a simplified, logically organized keyboard with an LCD display readout. The electrical equipment is designed for outlet and for car battery-operation, or for (optional) battery use. The controls allow each mother to customize the settings through a flexible system for adjusting vacuum and cycles. For both the Carum and Calypso breast pumps, the vacuum level remains stable when the user changes the cycle setting. Likewise, the cycle level remains stable when the user changes the vacuum setting. A non-sterile pump set is included for collection and storage of milk. Three models of ARDO Powered Breast Pumps are available: - -Calvpso with battery compartment and outlet adapter: - -Carum with outlet cord: and - -Carum with built in rechargeable battery and outlet cord. Accessories for Carum include: - -Power cord: - -Protective carrying case; - Car adapter (12VDC); - - -Trolley; - Bottle holder: - - -EasvFreeze holder: - EasyFreeze bag; and - - -PumpSets. Accessories for Calvpso include: - Power cord; - - Bottle holder; - - Nylon bags for accessories and for the PumpSet; - - -EasyFreeze bag; - -Breastfeeding bag (Shoulder Bag consisting of cold bag, cooling elements, Calvpso bag and Pumpset bag); and - -Pumpsets.
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    K Number
    K011601
    Device Name
    ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX
    Manufacturer
    ARDO MEDICAL AG
    Date Cleared
    2001-06-08

    (15 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARDO MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
    Device Description
    The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.
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