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510(k) Data Aggregation

    K Number
    K253412

    Validate with FDA (Live)

    Device Name
    Tablo Hemodialysis System (PN-0008000, PN-0006000U)
    Manufacturer
    Outset Medical, Inc.
    Date Cleared
    2026-01-26

    (118 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K190793,K210782,K232776,K233335
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K190793, K210782, K232776

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tablo® Hemodialysis System and TabloCart™ are indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility, and/or in the home. Treatments must be administered under a physician's prescription and observed by a trained individual who is considered competent in the use of the device. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

    Device Description

    The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consists of:

    1. Tablo Console
    2. Tablo Cartridge

    The proposed modifications for Tablo Hemodialysis System (Console) does not affect the functionality of the Tablo cartridge, which was cleared under K190793 and K210782.

    The TabloCart with Prefiltration Drawer ("TabloCart") is an optional accessory to the Tablo Hemodialysis System that raises the height of the system, and features large, 360° rotating wheels to aid in system mobility. The Prefiltration Drawer features two replaceable cartridge filters (configurable with either two sediment (2S), two carbon (2C) or one sediment filter, and one carbon filter (SC)) that serve as "prefilters" to help remove sediment and/or chlorine/chloramines from supply water before it enters the Tablo's integrated water purification system.

    The Tablo Hemodialysis System is designed to operate and achieve its intended use with or without use of the optional TabloCart. The TabloCart consists of TabloCart Wheeled Platform, Fluidics Drawer and Software. The Tablo Hemodialysis System uses its integrated water purification system, consisting of carbon, sediment, RO, and ultra-filters, to generate AAMI-quality water for dialysate fluid, even where the water is prefiltered using the TabloCart.

    The proposed modifications for Tablo Hemodialysis System (Console) does not affect the functionality of the Tablo Cart, which was cleared under K232776.

    AI/ML Overview

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