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

    HemoCare Hemodialysis System

    K Number: K233557 · Decision Jul 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    13
    Review Days
    249

    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
    HemoCare Hemodialysis System
    K Number
    K233557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development
    Date Received
    November 6, 2023
    Decision Date
    July 12, 2024
    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 Deka Research and Development

    K Number Device Name
    K261672 twiist Automated Insulin Delivery (AID) System
    K261530 iiSure Infusion Set
    K243841 Sparta Infusion Set for Insulin
    K240920 HemoCare Bicarbonate Concentrate Set (BCS)
    K240256 Remunity System
    K241178 DEKA ACE Pump System
    K234055 DEKA Loop
    K233952 DEKA ACE Pump System
    K232316 DEKA Infusion System, DEKA Administration Set
    K213536 DEKA ACE Pump System
    Search all 13 clearances from Deka Research and Development →