đź“‹ FDA Reference
tablo r hemodialysis system tablocart with prefiltration drawer
Outset Medical
Summary: The Tablo R Hemodialysis System is a portable dialysis machine used for renal replacement therapy in patients with kidney failure. It is typically used by nephrologists and dialysis nurses in both clinical and home settings.
FDA Clearance Information
Pathway
510K
Number
K232776 ↗
Decision Date
May 3, 2024
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Tablo R Hemodialysis System by Outset Medical was cleared via the FDA 510k pathway on May 3, 2024. It is classified as a Class 2 device under product code KDI.
What It Is
The Tablo R Hemodialysis System is a compact and user-friendly hemodialysis machine designed to provide renal replacement therapy. It integrates fluid management, dialysate production, and treatment delivery in one system. The device is equipped with a prefiltration drawer to enhance the filtration process, making it suitable for both clinical and home use. Its design aims to simplify dialysis procedures and improve patient outcomes.
Clinical Applications
The Tablo R Hemodialysis System is commonly used in outpatient dialysis centers, hospitals, and increasingly in home settings for patients with chronic kidney disease requiring hemodialysis. Nephrologists and dialysis nurses use this system to manage patients with end-stage renal disease (ESRD). Its portability and ease of use make it ideal for patients who prefer home dialysis, offering flexibility and independence.
Indications for Use
This device is indicated for patients with kidney failure who require hemodialysis to remove waste products and excess fluid from the blood. It is suitable for both acute and chronic dialysis needs, providing a versatile solution for various patient conditions.
Practical Considerations
The Tablo R Hemodialysis System is designed for ease of use, with intuitive controls and a compact design that fits into smaller spaces. It is compatible with standard dialysis supplies and requires minimal setup time. Clinicians should ensure proper training for home use to maximize 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 kidney failure, helping to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in both clinical settings and for home dialysis care.
What are the FDA-cleared indications?
The device is indicated for use in patients with kidney failure who require hemodialysis, suitable for both acute and chronic conditions.
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.