BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BD Insyte™ IV Catheter

    K Number: K252137 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    36
    Review Days
    268

    Basic Information

    Device Name
    BD Insyte™ IV Catheter
    K Number
    K252137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Infusion Therapy Systems, Inc.
    Date Received
    July 8, 2025
    Decision Date
    April 2, 2026
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Becton Dickinson Infusion Therapy Systems, Inc.

    K Number Device Name
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    K251155 BD Cathena™ Safety IV Catheter
    K251654 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
    K250682 BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    K241586 PIVO™ Pro Needle-free Blood Collection Device
    K233529 BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    K230865 PIVO™ Pro Needle-free Blood Collection Device
    K231239 Nexiva™ Closed IV Catheter System with NearPort™ IV Access
    K220584 BD Cathena Safety IV Catheter
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