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

    PRISMAFLO II

    K Number: K082758 · Decision Dec 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    6
    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
    PRISMAFLO II
    K Number
    K082758
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stihler Electronic GmbH
    Date Received
    September 19, 2008
    Decision Date
    December 19, 2008
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

    Similar 510(k) Clearances

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

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

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

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

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

    Blood Tubing Lines for Hemodialysis AV06C-E

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

    Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

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

    CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

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

    CAREline Airless Hemodialysis Blood Tubing Sets

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

    Other Clearances by Stihler Electronic GmbH

    K Number Device Name
    K202197 Astopad Patient Warming System
    K082765 ASTOFLO PLUS
    K020103 PRISMAFLO
    K991159 PRISMATHERM II, ASTOLINE
    K991160 ASTOTHERM PLUS, ASTOTUBES, ASTOLINE