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

    KF-E SERIES OF HOLLOW FIBER DIALYZERS

    K Number: K812353 · Decision Sep 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    22
    Review Days
    28

    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
    KF-E SERIES OF HOLLOW FIBER DIALYZERS
    K Number
    K812353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medisystems Corp.
    Date Received
    August 19, 1981
    Decision Date
    September 16, 1981
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

    Similar 510(k) Clearances

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

    Hemoflow F3 and F4 Dialyzers

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

    NIPRO PUREFLUX-L HEMODIALYZER

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

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

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

    DISPOSABLE STORAGE CAP

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

    ULTRACONCENTRATOR SYSTEM

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

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

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

    Other Clearances by Medisystems Corp.

    K Number Device Name
    K062953 MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
    K010279 MEDISYSTEMS LUER ACCESS INJECTION SITE
    K002372 ACCESS ALERT GAUGE
    K994306 REVERSO
    K990803 MEDISYSTEMS BUTTONHOLE NEEDLE SETS
    K983076 MEDISYSTEMS TRANSDUCER PROTECTOR
    K971860 MEDISYSTEMS DIALYSIS PRIMING SETS
    K963668 MEDISYSTEMS PERITONEAL DIALYSIS SETS
    K970536 MEDISYSTEMS TRANDUCER PROTECTOR
    K953823 ARTERIAL VENOUS BLOOD TUBING SET
    Search all 22 clearances from Medisystems Corp. →