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

    SAFETY INFUSION SET

    K Number: K121908 · Decision Jul 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    10
    Review Days
    26

    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
    SAFETY INFUSION SET
    K Number
    K121908
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greiner Bio-One North America, Inc.
    Date Received
    June 29, 2012
    Decision Date
    July 25, 2012
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

    Similar 510(k) Clearances

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

    Profoject™ Safety Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Verisafe Safety Sterile Needles (SSN)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRESSONE™

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pen Needle

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

    Other Clearances by Greiner Bio-One North America, Inc.

    K Number Device Name
    K233979 VACUETTE® QUICKSHIELD Complete (Plus)
    K122687 BLOOD CULTURE HOLDER
    K113505 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
    K103041 VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
    K102774 VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
    K081929 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
    K072320 GREINER VACUETTE QUICKSHIELD COMPLETE
    K063357 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
    K061483 VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES