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tablo r hemodialysis system
Outset Medical
Summary: The Tablo R Hemodialysis System is a device used for renal replacement therapy in patients with kidney failure. It is primarily used by nephrologists and dialysis nurses in clinical and home settings.
FDA Clearance Information
Pathway
510K
Number
K223248 ↗
Decision Date
June 21, 2023
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Tablo R Hemodialysis System by Outset Medical was cleared through the FDA 510(k) pathway on June 21, 2023. It is a Class 2 device under product code KDI.
What It Is
The Tablo R Hemodialysis System is a hemodialysis machine designed to provide renal replacement therapy for patients with end-stage renal disease (ESRD). It simplifies the dialysis process by integrating water purification and dialysis delivery into a single unit. The system is designed to be user-friendly, with an intuitive touchscreen interface that guides users through setup and treatment, making it suitable for both clinical and home use.
Clinical Applications
This device is commonly used in nephrology clinics, dialysis centers, and increasingly in home settings for patients requiring chronic dialysis. It is suitable for adult patients with ESRD who need regular hemodialysis sessions. The system's design allows for flexibility in treatment locations, which can improve patient quality of life by reducing the need for frequent clinic visits.
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 a versatile solution for managing chronic kidney disease.
Practical Considerations
The Tablo R system is designed for ease of use, with features that support both professional and patient-led dialysis sessions. It typically requires standard dialysis supplies and is compatible with existing dialysis infrastructure. Clinicians should ensure proper training for patients using the system at home to optimize safety and efficacy.
Frequently Asked Questions
What is the Tablo R Hemodialysis System used for?
The Tablo R Hemodialysis System is used for providing hemodialysis treatment to patients with end-stage renal disease.
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 hemodialysis treatment in patients with kidney failure, suitable for use in clinical and home environments.
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.