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510(k) Data Aggregation

    K Number
    K242935
    Device Name
    Respiration Data Management Software (PAP Link PC)
    Manufacturer
    BMC Medical Co., Ltd.
    Date Cleared
    2025-01-15

    (112 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMC Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.
    Device Description
    The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.
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    K Number
    K213169
    Device Name
    BPAP System
    Manufacturer
    BMC Medical Co., Ltd.
    Date Cleared
    2022-12-05

    (433 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMC Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.
    Device Description
    The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient and multi-patients
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    K Number
    K211155
    Device Name
    Auto CPAP System
    Manufacturer
    BMC Medical Co., Ltd.
    Date Cleared
    2022-03-09

    (324 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMC Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home. Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use. LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.
    Device Description
    Auto CPAP System is a microprocessor controlled, blower-based system that generates continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 20 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway. The Auto CPAP System is designed and developed on the basis of the predicate device Luna CPAP and Auto CPAP System (K153387). The parameters and algorithms of the two devices, such as the treatment mode (CPAP and AutoCPAP), the pressure range (4 to 20 cm H2O), and the Respiratory Event Detection, are consistent. Compared with the predicate device, the subject device does not include a humidifier and an LCD screen. The parameters of subject device are displayed and set via the LightTrip App.
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