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510(k) Data Aggregation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NIBP cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

    Device Description

    The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

    The subject device includes reusable non-invasive Blood Pressure Cuff(NIBP) cuff, all the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

    The NIBP cuff is reusable device, Model BCS-X12 series and BCD-X12 series are made of PU synthetic leather (Cuff) and TPU (Air Hose), thereinto, the PU synthetic leather (Cuff) is the material used to contacting with the patient. Model BCS-X22 series and BCD-X22 series are made of Nylon (Cuff) and TPU (Air Hose), thereinto, and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

    The NIBP cuff comes in 28 different sizes to fit different population of different arm sizes. Of these, 14 models(BCS-X12 series and BCS-X22 series) of 28 use a single tube of air hose, while the other 14 models(BCD-X12 series and BCD-X22 series) use a double tube of air hose, which is used for different noninvasive blood pressure measurement system.

    AI/ML Overview

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    K Number
    K253109

    Validate with FDA (Live)

    Date Cleared
    2026-01-07

    (105 days)

    Product Code
    Regulation Number
    870.2700
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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