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510(k) Data Aggregation

    K Number
    K250322
    Device Name
    Respond OC Conserving Regulator (130-0800)
    Manufacturer
    Responsive Respiratory
    Date Cleared
    2025-07-24

    (170 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220591
    Device Name
    Proxima
    Manufacturer
    Dynasthetics LLC
    Date Cleared
    2022-12-15

    (289 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
    Device Description
    The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.
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    K Number
    K221014
    Device Name
    Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
    Manufacturer
    Effortless Oxygen. LLC
    Date Cleared
    2022-10-17

    (195 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.
    Device Description
    The Effortless Oxygen Conserver Systems (EOCS) is a microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver. Depending upon the model they have been designed for use in ambulatory, home and medical facility settings to supply medical-grade oxygen therapy to patients. The built in oxygen regulator reduces oxygen pressures from an oxygen cylinder or from hospital wall supplies. There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.
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    K Number
    K200401
    Device Name
    Apogee
    Manufacturer
    Incoba Ltd. d/b/a Dynaris
    Date Cleared
    2020-11-14

    (270 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.
    Device Description
    The proposed device, Apogee, senses each nostril independently through a bifurcated cannula and responds to the dynamic changes in nasal air-flow making a breath-to-breath determination of where to deliver the next bolus of oxygen: to the left, the right, or both nostrils. The Apogee Device is composed of the main components as detailed below: Control Unit, Control Board (Regulated Voltage Supply), Embedded Processor, User supplied Demand Cannula, The Apogee Bypass Cannula and Restrictor and Cylinder Tubing.
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    K Number
    K151506
    Device Name
    Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
    Manufacturer
    Salter Labs
    Date Cleared
    2016-03-11

    (281 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use is to deliver oxygen to the patient nasally, controlled by a demand system.
    Device Description
    The demand cannula is a special cannula designed to give adult and pediatric users of dual port oxygen conservation delivery system all the comfort and conveniences of a Salter-Style® cannula. Unique dual tubing delivers oxygen on demand through one tube while inspiratory / expiratory effort is also sensed through the other tube. Meets dual port device manufacturers' specifications.
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    K Number
    K131023
    Device Name
    THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
    Manufacturer
    MEDICAL PRODUCTS, LLC
    Date Cleared
    2013-10-11

    (182 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.
    Device Description
    Not Found
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    K Number
    K113111
    Device Name
    CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
    Manufacturer
    INOVO, INC.
    Date Cleared
    2011-12-08

    (49 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
    Device Description
    The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery(active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.
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    K Number
    K103392
    Device Name
    CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
    Manufacturer
    INOVO, INC.
    Date Cleared
    2010-12-17

    (28 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chad Therapeutics Evolution Model OM-900 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 7 liters per minute, in their home and for ambulatory use
    Device Description
    The Inovo Evolution is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors convert the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 7 liters per minute depending on the flow rate setting
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    K Number
    K090421
    Device Name
    MODEL 350G GAS CONSERVER
    Manufacturer
    INSPIRED TECHNOLOGIES, INC.
    Date Cleared
    2009-05-29

    (100 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.
    Device Description
    The Inspired Technologies Model 350G Gas Conserver is designed to extend the use time of oxygen cylinders. It contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. While the device is normally operated in the conserving mode, there is a continuous flow over-ride switch that allows 2 LPM of oxygen to bypass all valves for delivery to the patient. This continuous flow mode is typically used in the event of low or no battery power. In the conserving mode, the 350G Gas Conserver delivers oxygen to the patient by sensing inhalation via a pressure switch and opening one, two or both control valves for a specified period of time as determined by the microprocessor control algorithm. In the conserving mode, the device uses SmartDose™ technology to accomplish the oxygen savings. SmartDose™ senses the start of inhalation and releases a short "pulsed" dose at the very beginning of the inhalation cycle. The 350G Gas Conserver intended to be used by trained clinicians in the hospital, clinical or home care environments.
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    K Number
    K070740
    Device Name
    CHAD THERAPEUTICS BONSAI MODEL 800
    Manufacturer
    CHAD THERAPEUTICS, INC.
    Date Cleared
    2007-05-07

    (52 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Product Code :

    NFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.
    Device Description
    The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.
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