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

    BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

    K Number: K120823 · Decision Jun 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    88

    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
    BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
    K Number
    K120823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America, Design Cente
    Date Received
    March 19, 2012
    Decision Date
    June 15, 2012
    Product Code
    FJK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

    Similar 510(k) Clearances

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

    NovaLine Tubing Set for Hemodialysis (BL 124)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VITAL Tubing Sets for Hemodialysis

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Moda-flx Hemodialysis System™ Cartridge (102121-001 )

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CombiSet Hemodialysis Blood Tubing Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tablo Cartridge

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Fresenius Medical Care North America, Design Cente

    K Number Device Name
    K123630 FRESENIUS LIBERTY CYCLER
    K121421 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
    K120505 FRESENIUS 2008T HEMODIALYSIS MACHINE
    K101715 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573