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

    Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer

    K Number: K232776 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    9
    Review Days
    235

    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
    Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
    K Number
    K232776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Outset Medical, Inc.
    Date Received
    September 11, 2023
    Decision Date
    May 3, 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 Outset Medical, Inc.

    K Number Device Name
    K253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)
    K233335 Tablo® Hemodialysis System
    K223248 Tablo® Hemodialysis System
    K211370 Tablo Hemodialysis System
    K210782 Tablo Cartridge
    K200741 Tablo Hemodialysis System
    K190793 Tablo Hemodialysis System, Tablo Cartridge
    K160881 Tablo Console