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

    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

    K Number: K030385 · Decision Apr 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    69

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
    K Number
    K030385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories America, Inc.
    Date Received
    February 5, 2003
    Decision Date
    April 15, 2003
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.

    iiSure Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PuraCath Firefly Needleless Connector IT (9005)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Pump Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ™ IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Kawasumi Laboratories America, Inc.

    K Number Device Name
    K102890 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
    K001423 KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
    K001426 KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
    K001424 KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
    K001043 KAWASUMI LABORATORY BLOOD DRAWING KIT