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510(k) Data Aggregation

    K Number
    K251341

    Validate with FDA (Live)

    Date Cleared
    2026-01-16

    (261 days)

    Product Code
    Regulation Number
    876.5820
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines for exclusive use with AK98 (model BLU014E, BLU015E, BLU021E, BLU022E, BLU025E), Fresenius 2008 series (model BLU001E, BLU002E, BLU003E, BLU004E, BLU005E, BLU006E, BLU007E, BLU008E, BLU009E, BLU010E, BLU011E, BLU012E, BLU013E, BLU016E, BLU017E, BLU018E, BLU020E, BLU023E, BLU024E, BLU029E, BLU030E, BLU063E), Fresenius 5008X (model BLU026E, BLU027E) or Bbraun Dialog series Hemodialysis system (model BLU019E, BLU028E). 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 VITAL Tubing Sets for Hemodialysis consists of an Arterial line and a Venous line. The tubing is soft, transparent, smooth and non-kink to ensure the good liquidity.

    The proposed models have the same principles, intended use and manufacturing process, but have some difference in the product configuration and dimension. The typical/representative model is BLU063E among all the models due to it has the most complex structure for Ethylene Oxide sterilization which covers all the components of the other models and the distance from the closed end and ventilated end is the farthest.

    The proposed devices are provided in sterile condition, it is subject to ethylene oxide sterilization prior to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.

    AI/ML Overview

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