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2008 hemodialysis sorbent system
Renal Solutions
Summary: The 2008 hemodialysis sorbent system by Renal Solutions is a device designed for hemodialysis using sorbent technology. It is primarily used in dialysis settings to purify spent dialysate. Key evidence highlights its clinical application in recycling dialysate.
FDA Clearance Information
Pathway
510K
Number
K093362 ↗
Decision Date
August 13, 2010
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The 2008 hemodialysis sorbent system was cleared by the FDA via the 510(k) pathway on August 13, 2010. It is manufactured by Renal Solutions and classified as a Class 2 device.
What It Is
The 2008 hemodialysis sorbent system is a medical device that utilizes sorbent technology to purify spent dialysate during hemodialysis. It is intended for use in clinical settings to support patients requiring dialysis by recycling dialysate.
Clinical Applications
This device is commonly used in dialysis centers and potentially in home dialysis settings. It provides a practical solution for patients requiring regular hemodialysis by enabling the reuse of dialysate, thus reducing the need for large volumes of fresh dialysate.
Evidence Summary
The available literature includes five studies, ranging from 2008 to 2009, with various study designs such as RCTs and case series. These studies explore the clinical application and initial experiences with sorbent hemodialysis technology.
Reported Outcomes
Published studies report that the 2008 hemodialysis sorbent system effectively recycles spent dialysate, offering a viable option for home hemodialysis. Clinical experiences highlight the system's ability to maintain dialysis efficacy while reducing dialysate waste.
Safety Profile
Reported complications include potential immunologic and non-immunologic reactions due to continuous blood-artificial membrane interactions. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to assess long-term outcomes and safety in diverse patient populations. The studies primarily focus on initial clinical experiences rather than extensive efficacy trials.
Frequently Asked Questions
What are the clinical indications for 2008 hemodialysis sorbent system?
The device is indicated for use in hemodialysis to purify spent dialysate, particularly in settings where dialysate recycling is beneficial.
What outcomes have been reported in clinical studies?
Studies report effective dialysate recycling and maintenance of dialysis efficacy, making it suitable for home hemodialysis applications.
What complications have been reported?
Safety data indicate potential immunologic and non-immunologic reactions due to continuous blood-artificial membrane interactions.
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.