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

    METRICARE EMPTY CONTAINER SYSTEMS

    K Number: K895922 · Decision Aug 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    315

    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
    METRICARE EMPTY CONTAINER SYSTEMS
    K Number
    K895922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Metrix Co.
    Date Received
    October 11, 1989
    Decision Date
    August 22, 1990
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

    Similar 510(k) Clearances

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

    ADRx™ Admixture Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vial Adapter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Bag Decanter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FlowArt® Vial Access Device Vented

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HyHub™ and HyHub™ Duo Vial Access Devices

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

    Other Clearances by Metrix Co.

    K Number Device Name
    K030888 EVA EMPTY SOLUTION CONTAINER
    K895924 METRICARE DRUG RESERVOIRS
    K895923 METRICARE ENTERAL FEEDING SYSTEM
    K761201 ECHO-CARDIOTRACE, AUTOMATIC