📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Hemodialysis treatment for patients with renal failure.
- Removal of metabolic waste products and excess fluid from the blood using an extracorporeal blood circuit and dialyzer.
Clinical Applications
- Routine maintenance hemodialysis for patients with end-stage renal disease.
- Hemodialysis provided in an outpatient dialysis center.
- Hemodialysis provided in a hospital or other qualified clinical setting.
- Renal replacement therapy when a clinician determines that hemodialysis is indicated.
Practical Considerations
- The system requires compatible extracorporeal blood tubing, a dialyzer, dialysate supplies, and an appropriately treated water or dialysis-fluid system.
- Treatment settings, including blood-flow rate, dialysate flow, treatment time, ultrafiltration volume, and anticoagulation, must be prescribed and monitored by qualified dialysis personnel.
- The device is not an implant and does not have a patient-specific implant size; compatibility depends on the approved blood circuit, dialyzer, access equipment, and machine configuration.
- Hemodialysis requires reliable vascular access, such as an arteriovenous fistula, arteriovenous graft, or dialysis catheter.
- This is an external dialysis machine, not an MRI-compatible implant. It should not be taken into the MRI scanner room unless the manufacturer and facility have specifically assessed its MRI-environment compatibility.
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.