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tablo hemodialysis system tablo cartridge
Outset Medical
Summary: The Tablo Hemodialysis System by Outset Medical is an integrated device for dialysis, cleared for acute, chronic, and home use. Key evidence supports its efficacy in prolonged therapy and self-care training.
FDA Clearance Information
Pathway
510K
Number
K190793 ↗
Decision Date
December 12, 2019
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 December 12, 2019. 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 dialysis device featuring integrated water purification and on-demand dialysate production. It is designed for use in acute, chronic, and home settings, providing flexibility and ease of use for both patients and clinicians.
Clinical Applications
The device is commonly used in hospital settings for acute dialysis and in home settings for chronic dialysis patients. It is particularly useful for patients requiring prolonged dialysis sessions and those capable of self-care.
Evidence Summary
The available literature includes three studies: two published in 2021 and 2022, and one ongoing registry study. These studies include randomized controlled trials and prospective analyses, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the Tablo Hemodialysis System effectively supports prolonged therapy sessions up to 24 hours and facilitates self-care training for home dialysis patients. The device has been shown to integrate seamlessly into various clinical settings, achieving clinical goals and reducing costs.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile for both acute and home use. No significant safety concerns were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term data. Further research is needed to evaluate the device's performance in diverse patient populations and over extended periods.
Frequently Asked Questions
What are the clinical indications for Tablo Hemodialysis System?
The Tablo Hemodialysis System is indicated for use in acute, chronic, and home dialysis settings, providing flexibility for various patient needs.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful prolonged therapy sessions and effective self-care training, with the device achieving clinical goals and reducing costs.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with no significant safety concerns reported in the studies reviewed.
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.