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510(k) Data Aggregation

    K Number
    K243607
    Device Name
    Moda-flx Hemodialysis System™ Cartridge (102121-001 )
    Manufacturer
    Diality, Inc.
    Date Cleared
    2024-12-20

    (29 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System ™
    Device Description
    The Moda-flx Hemodialysis System™ Cartridge is a single use blood tubing set that provides extracorporeal access during hemodialysis and is only compatible with Moda-flx Hemodialysis System™
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    K Number
    K213992
    Device Name
    CombiSet Hemodialysis Blood Tubing Set
    Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Cleared
    2023-05-31

    (526 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.
    Device Description
    The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set. The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access.
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    K Number
    K210782
    Device Name
    Tablo Cartridge
    Manufacturer
    Outset Medical, Inc.
    Date Cleared
    2021-11-26

    (255 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
    Device Description
    The Tablo Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.
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    K Number
    K202796
    Device Name
    SANSIN Tubing Sets for Hemodialysis
    Manufacturer
    Jiangxi Sanxin Medtec Co., Ltd.
    Date Cleared
    2021-09-06

    (348 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SANSIN Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.
    Device Description
    The propose device, SANSIN Tubing Sets for Hemodialysis, is used to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The proposed devices are provided sterile and single use. The proposed device is intended to be used with Fresenius 2008K Home Hemodialysis manufactured by Fresenius Medical Care North America, which is a hemodialysis delivery system being submitted to FDA for premarket notification (K124035). The proposed device mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessories such as priming piece, drain bag, priming needle, fluid replacement tube, connecting tube, monitor and transducer protector. The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN.
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    K Number
    K201866
    Device Name
    NovaLine Tubing Sets for Hemodialysis
    Manufacturer
    Bain Medical Equipment(Guangzhou) Co., Ltd.
    Date Cleared
    2021-03-10

    (246 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.
    Device Description
    The proposed devices, NovaLine Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessory which is recirculating connector. There are two models BL 11 and BL 12, The main difference between BL 11 and BL 12 is the Drip chamber on the arterial line. There is drip chamber on the arterial line of BL 12, there is no drip chamber on the arterial line of BL 11. The BL 12 has more drip chambers than the BL 11 on the whole tubing. The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
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    K Number
    K171952
    Device Name
    Dimesol Tubing Sets for Hemodialysis
    Manufacturer
    Dimesol, Inc.
    Date Cleared
    2018-03-30

    (274 days)

    Product Code
    FJK, FKB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.
    Device Description
    The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).
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    K Number
    K161582
    Device Name
    DORA Tubing Sets for Hemodialysis
    Manufacturer
    Bain Medical Equipment (Guangzhou) Co., Ltd
    Date Cleared
    2017-06-16

    (373 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.
    Device Description
    The proposed devices, DORA Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as two accessories which are recirculate connector and drainage bag. They are available in five (5) models, following very similar design principles, and has some differences in dimensions and configurations. The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
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    K Number
    K150304
    Device Name
    Oxyless Blood Tubing Set
    Manufacturer
    Oxyless Ltd
    Date Cleared
    2016-02-24

    (383 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.
    Device Description
    The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro. The components of the Oxyless Blood Tubing Set include pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines and tubing clamps. Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free. Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.
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    K Number
    K140841
    Device Name
    TABLO CARTRIDGE
    Manufacturer
    HOME DIALYSIS PLUS
    Date Cleared
    2014-09-11

    (162 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.
    Device Description
    The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.
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    K Number
    K112628
    Device Name
    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2012-09-28

    (385 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.
    Device Description
    The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors. The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.
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