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510(k) Data Aggregation

    K Number
    K222644
    Device Name
    Nihon Kohden NKV-440 Ventilator System
    Manufacturer
    Nihon Kohden OrangeMed, Inc.
    Date Cleared
    2023-05-31

    (272 days)

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

    Nihon Kohden OrangeMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
    Device Description
    The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.
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    K Number
    K213521
    Device Name
    Nihon Kohden NKV-330 Ventilator System
    Manufacturer
    Nihon Kohden OrangeMed, Inc.
    Date Cleared
    2022-07-01

    (240 days)

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

    Nihon Kohden OrangeMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.
    Device Description
    The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.
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    K Number
    K192307
    Device Name
    Nihon Kohden NKV-550 Series Ventilator System
    Manufacturer
    Nihon Kohden OrangeMed, Inc.
    Date Cleared
    2020-01-10

    (137 days)

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

    Nihon Kohden OrangeMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
    Device Description
    The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.
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    K Number
    K181695
    Device Name
    Nihon Kohden NKV-550 Series Ventilator System
    Manufacturer
    Nihon Kohden OrangeMed, Inc.
    Date Cleared
    2018-12-07

    (163 days)

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

    Nihon Kohden OrangeMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
    Device Description
    The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.
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    K Number
    K160988
    Device Name
    Biopor, AOC Porous Polyethylene, Cerepor
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2016-07-14

    (97 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.
    Device Description
    Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.
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    K Number
    K141880
    Device Name
    BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2015-04-16

    (279 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.
    Device Description
    Porous High Density Polyethylene (HDPE) Surgical Implant
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    K Number
    K142686
    Device Name
    StimPad OTC
    Manufacturer
    AEMED, INC.
    Date Cleared
    2014-12-18

    (87 days)

    Product Code
    NUH, GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.
    Device Description
    The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032). The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
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    K Number
    K132198
    Device Name
    ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2013-09-12

    (58 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain" is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain™ is a water-soluble, wax-like surgical implant material that will adhere to itself utilized directly and a first application of firm pressure. Adaptain " is designed to be utilized directly out of the package. The implant will soften as it is warmed. The surface of the implant becomes lubricious when wet, and the implant does not swell as it dissolves. Adaptain™ is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™) and contains no other additives or colorants. Adaptain is supplied in a number of forms including bars, sticks, granules and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ is provided sterile by irradiation and must not be resterilized.
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    K Number
    K122561
    Device Name
    ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2012-11-27

    (97 days)

    Product Code
    KHJ, PRE
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain FastWrap™ is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional . handling and manipulation, if so desired. Adaptain FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.
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    K Number
    K120220
    Device Name
    ADAPTAIN SOLUBLE IMPLANT MATERIAL
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2012-06-06

    (133 days)

    Product Code
    KHJ, PRE
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
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