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tablo r hemodialysis system
Outset Medical
Summary: The Tablo R Hemodialysis System is a medical device used for providing hemodialysis treatment to patients with renal failure. It is typically used by nephrologists and dialysis nurses in both clinical and home settings.
FDA Clearance Information
Pathway
510K
Number
K233335 ↗
Decision Date
December 5, 2023
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Tablo R Hemodialysis System, manufactured by Outset Medical, received FDA clearance through the 510(k) pathway on December 5, 2023. It is classified as a Class 2 device under product code KDI.
What It Is
The Tablo R Hemodialysis System is an advanced hemodialysis machine designed to simplify the dialysis process. It integrates water purification, dialysate production, and dialysis delivery into a single compact unit. This system is designed to be user-friendly, allowing for both clinical and home use, and aims to improve patient access to dialysis by reducing the complexity and infrastructure typically required.
Clinical Applications
The Tablo R Hemodialysis System is commonly used in nephrology practices and dialysis centers, as well as in home settings for patients who require regular dialysis. It is suitable for adult patients with chronic kidney disease or acute kidney injury who need renal replacement therapy. This device is particularly beneficial in settings where space and resources are limited, as it combines multiple functions into one unit.
Indications for Use
The FDA-cleared indications for the Tablo R Hemodialysis System include providing hemodialysis treatment for patients with kidney failure. It is intended for use in both clinical settings and at home, offering flexibility for patients who require ongoing dialysis therapy.
Practical Considerations
The Tablo R Hemodialysis System is designed to be compact and user-friendly, making it suitable for home use. It is compatible with standard dialysis consumables and requires minimal setup. Clinicians should ensure proper training for patients who will use the device at home to ensure safety and efficacy.
Frequently Asked Questions
What is Tablo R Hemodialysis System used for?
The Tablo R Hemodialysis System is used for providing hemodialysis treatment to patients with renal failure.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in both clinical and home settings.
What are the FDA-cleared indications?
The device is indicated for providing hemodialysis treatment to patients with kidney failure, suitable for both clinical and home use.
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.