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510(k) Data Aggregation

    K Number
    K251745

    Validate with FDA (Live)

    Date Cleared
    2025-12-16

    (193 days)

    Product Code
    Regulation Number
    870.1120
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Welch Allyn FlexiPort Blood Pressure Cuffs are intended to be used for patient health screening assessment to determine patient's systolic/diastolic blood pressure when used in conjunction with non-automated and automated sphygmomanometers.

    Welch Allyn FlexiPort Blood Pressure Cuffs are noninvasive blood pressure cuffs intended for use in conjunction with non-automated and automated sphygmomanometers to determine blood pressure in pediatric through adult patients.

    FlexiPort Blood Pressure Cuffs are intended to be used by a clinically trained medical professional.

    Device Description

    Welch Allyn FlexiPort Blood Pressure Cuffs product line consists of Reuse, Soft & Vinyl Blood Pressure Cuffs used for patient health screening assessment to determine the patient's systolic/diastolic blood pressure when used in conjunction with non-automated and automated sphygmomanometers. This product line was previously cleared under 510(k) premarket notification K070060 on December 18, 2007.

    Welch Allyn FlexiPort Blood Pressure Cuffs are designed with the FlexiPort, a port connector which can rotate 360 degrees to reduce tube kinking and a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers. The FlexiPort feature allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another. The cuff can then be used universally within a facility on multiple devices.

    The following are the types of FlexiPort Blood Pressure Cuffs available with the FlexiPort feature.
    a. Welch Allyn FlexiPort Reusable Blood Pressure Cuffs (also referred as Reuse Blood Pressure Cuffs).
    b. Welch Allyn FlexiPort Soft Blood Pressure Cuffs (also referred as Soft Blood Pressure Cuffs).
    c. Welch Allyn FlexiPort Vinyl Blood Pressure Cuffs (also referred as Vinyl Blood Pressure Cuffs).

    AI/ML Overview

    N/A

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