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

    CYLER/HEATER FOR PERITONEAL DIALYSIS

    K Number: K791584 · Decision Nov 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    30
    Review Days
    91

    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
    CYLER/HEATER FOR PERITONEAL DIALYSIS
    K Number
    K791584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Medical Products, Inc.
    Date Received
    August 17, 1979
    Decision Date
    November 16, 1979
    Product Code
    KPF
    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
    KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal

    Similar 510(k) Clearances

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

    RENALSOFT

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

    RENAL LINK

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

    CYBERREN

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

    PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

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

    TOTAL CONTAINMENT DEVICE

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

    AMICON EQUALINE FLUID BALANCE SYSTEM

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

    Other Clearances by American Medical Products, Inc.

    K Number Device Name
    K922290 SINGLE-STEP PREGNANCY, HCG TEST
    K862221 E-Z CLEAN
    K861251 AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
    K830881 AMPERCIDE DISINFECTANT ACCESSORY TO -
    K823827 AMP 80/2 OUTFLOW MONITOR MODIFICATION
    K822545 CCPD CYCLER SET W/5 PRONGED CONNECTOR
    K822546 SAFE LOCK SEALING CAPS
    K822543 CAPD SAFE LOCK TRANSFER SET
    K822551 AMP CAPD UNISPIKE AMINISTRATION SET
    K822544 SAFE LOCK SEALING CAP L
    Search all 30 clearances from American Medical Products, Inc. →