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tablo hemodialysis system
Outset Medical
Summary: The Tablo Hemodialysis System is an innovative device for kidney replacement therapy, suitable for acute, chronic, and home settings. Key evidence highlights its ability to maintain clinical outcomes while reducing costs and resource use.
FDA Clearance Information
Pathway
510K
Number
K200741 ↗
Decision Date
March 31, 2020
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Tablo Hemodialysis System was cleared by the FDA via the 510(k) pathway on March 31, 2020. It is manufactured by Outset Medical and classified as a Class 2 device.
What It Is
The Tablo Hemodialysis System is an all-in-one device that integrates water purification, on-demand dialysate production, and wireless data transmission. It is intended for use in acute, chronic, and home dialysis settings.
Clinical Applications
Commonly used in hospital ICUs and home settings, the Tablo system is designed for patients with acute kidney injury or end-stage kidney disease. It supports prolonged intermittent renal replacement therapy and other dialysis modalities.
Evidence Summary
The literature includes 14 studies, comprising RCTs, prospective, and retrospective analyses, published between 2021 and 2025. These studies explore various clinical applications and outcomes of the Tablo system.
Reported Outcomes
Published studies report that the Tablo system effectively maintains clinical outcomes while reducing dialysis-related costs and nursing staff burden. It also supports prolonged therapy durations and innovative dosing strategies for critically ill patients.
Safety Profile
Reported complications include the potential for altered antibiotic clearance due to varying effluent rates and treatment durations. However, no specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies. Further research is needed to explore the full range of clinical outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Tablo Hemodialysis System?
The Tablo system is indicated for use in patients requiring hemodialysis, including those with acute kidney injury and end-stage kidney disease.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of clinical outcomes, reduced costs, and decreased nursing burden with the use of the Tablo system.
What complications have been reported?
Safety data indicate potential issues with antibiotic clearance due to variable treatment parameters, but specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.