đź“‹ FDA Reference
allient sorbet hemodialysis system model 1100
Renal Solutions
Summary: The Allient Sorbet Hemodialysis System Model 1100 is a medical device used for hemodialysis in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K060381 ↗
Decision Date
May 24, 2006
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The Allient Sorbet Hemodialysis System Model 1100, manufactured by Renal Solutions, was cleared via the FDA 510k pathway on May 24, 2006. It is classified as a Class 2 device under product code FKT.
What It Is
The Allient Sorbet Hemodialysis System Model 1100 is a hemodialysis machine designed to remove waste products and excess fluid from the blood when the kidneys are not functioning properly. It operates by circulating the patient's blood through a dialyzer, where diffusion and filtration occur. This system is part of the essential equipment in dialysis centers and is designed to be reliable and efficient for routine dialysis sessions.
Clinical Applications
This device is commonly used in outpatient dialysis centers, hospitals, and sometimes in home settings for patients with end-stage renal disease (ESRD). Nephrologists and dialysis nurses use it to manage chronic kidney disease patients who require regular dialysis. It is suitable for adult and pediatric patients, with adjustments made based on the patient's size and dialysis needs.
Indications for Use
The Allient Sorbet Hemodialysis System is indicated for patients with renal failure who require hemodialysis to manage their condition. It is suitable for those with chronic kidney disease or acute kidney injury needing renal replacement therapy.
Practical Considerations
The system is compatible with standard dialysis setups and requires connection to a water treatment system. It is important to ensure proper calibration and maintenance to optimize performance. Clinicians should be familiar with the device's interface and troubleshooting procedures.
Frequently Asked Questions
What is the Allient Sorbet Hemodialysis System used for?
It is used for performing hemodialysis in patients with renal failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis specialties typically use this device in clinical settings such as dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring hemodialysis, including those with chronic kidney disease or acute kidney injury.
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.