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tablo hemodialysis system
Outset Medical
Summary: The Tablo Hemodialysis System is a versatile device for dialysis in acute, chronic, and home settings. Key evidence highlights its ability to reduce costs and integrate seamlessly into clinical settings.
FDA Clearance Information
Pathway
510K
Number
K211370 ↗
Decision Date
July 29, 2022
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Tablo Hemodialysis System was cleared via the FDA 510(k) pathway on July 29, 2022. Manufactured by Outset Medical, it is classified as a Class 2 device.
What It Is
The Tablo Hemodialysis System is an all-in-one dialysis device featuring integrated water purification and on-demand dialysate production. 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 requiring hemodialysis.
Evidence Summary
The literature includes 14 studies, ranging from case reports to randomized controlled trials, 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 reduces dialysis-related costs and nursing staff burden while maintaining clinical outcomes. It also supports prolonged therapy durations, such as 24-hour treatments, in critical care settings.
Safety Profile
Reported complications include potential variations in antibiotic clearance due to different effluent rates and treatment durations. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials. Further research is needed to explore long-term 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 with acute kidney injury or end-stage kidney disease requiring hemodialysis.
What outcomes have been reported in clinical studies?
Studies report reduced dialysis-related costs and nursing burden, with effective clinical outcomes in both acute and chronic settings.
What complications have been reported?
Safety data indicate potential variations in antibiotic clearance, but no significant adverse events have been reported.
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.