BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

    K Number: K193670 · Decision Dec 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    4
    Review Days
    358

    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
    SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
    K Number
    K193670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quanta Dialysis Technologies, Ltd.
    Date Received
    December 31, 2019
    Decision Date
    December 23, 2020
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

    Similar 510(k) Clearances

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

    NxStage System One with NxView

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

    ELISIO™-H

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

    multiFlux 130 (F00013123); multiFlux 160 (F00013124)

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

    Tablo Hemodialysis System (PN-0008000, PN-0006000U)

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

    FX CorAL 40; FX CorAL 50

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

    Purema H Hemoconcentrator - Pediatric

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

    Other Clearances by Quanta Dialysis Technologies, Ltd.

    K Number Device Name
    K242269 SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
    K222067 SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
    K210661 SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset