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510(k) Data Aggregation

    K Number
    K242736
    Device Name
    Portable Oxygen Concentrator (Spirit-3)
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., LTD.
    Date Cleared
    2025-06-05

    (267 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
    Device Description
    Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.
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    K Number
    K242718
    Device Name
    Portable Oxygen Concentrator (P2-TOC)
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd
    Date Cleared
    2025-02-28

    (171 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
    Device Description
    The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user. The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" . In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
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    K Number
    K240561
    Device Name
    Rugged Oxygen Generator (ROG) (RO01-00001)
    Manufacturer
    Molecular Products Ltd.
    Date Cleared
    2024-12-06

    (281 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.
    Device Description
    The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable. Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.
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    K Number
    K240840
    Device Name
    Oxygen Concentrator (ZY-10AB/115)
    Manufacturer
    Foshan Care Medical Technology Co., Ltd.
    Date Cleared
    2024-12-06

    (254 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
    Device Description
    The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.
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    K Number
    K230969
    Device Name
    Oxygen Concentrator
    Manufacturer
    Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
    Date Cleared
    2023-11-09

    (218 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
    Device Description
    JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides high concentration of oxygen directly to patient/user through a nasal cannula or other methods. The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 93% oxygen to the patient.
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    K Number
    K230702
    Device Name
    Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd.
    Date Cleared
    2023-10-18

    (218 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
    Device Description
    Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
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    K Number
    K223740
    Device Name
    Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
    Manufacturer
    Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
    Date Cleared
    2023-10-05

    (295 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Concentrator is intended to be used by patients with require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.
    Device Description
    Not Found
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    K Number
    K222920
    Device Name
    Oxygen concentrator
    Manufacturer
    Zhengzhou Olive Electronic Technology Co., Ltd.
    Date Cleared
    2023-07-20

    (297 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
    Device Description
    The oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.
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    K Number
    K230052
    Device Name
    Inogen Rove 6
    Manufacturer
    Inogen, Inc
    Date Cleared
    2023-06-30

    (175 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
    Device Description
    The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile. The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable. The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
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    K Number
    K223379
    Device Name
    Portable Oxygen Concentrator (Model: P2-E7, P2-E)
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd.
    Date Cleared
    2023-06-22

    (227 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.
    Device Description
    Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters. Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).
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