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

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

    K Number: K253412 · Decision Jan 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    9
    Review Days
    118

    Basic Information

    Device Name
    Tablo Hemodialysis System (PN-0008000, PN-0006000U)
    K Number
    K253412
    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 30, 2025
    Decision Date
    January 26, 2026
    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

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    Other Clearances by Outset Medical, Inc.

    K Number Device Name
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    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