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high efficiency hemodialysis system
Travenol Laboratories
Summary: The high efficiency hemodialysis system by Travenol Laboratories is designed for renal replacement therapy. It is FDA 510k cleared and supported by 13 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K861776 ↗
Decision Date
June 19, 1986
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The high efficiency hemodialysis system was cleared through the FDA 510k pathway on June 19, 1986. Manufactured by Travenol Laboratories, it is classified as a Class 2 device.
What It Is
The high efficiency hemodialysis system is a medical device used in renal replacement therapy to filter waste products and excess fluids from the blood. It is intended for patients with end-stage renal disease requiring dialysis.
Clinical Applications
This device is commonly used in clinical settings for patients with chronic kidney disease or acute kidney injury requiring dialysis. It is particularly relevant in managing end-stage renal disease.
Evidence Summary
The available literature includes 13 studies, comprising various study types such as RCTs and case series, published between 2008 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the high efficiency hemodialysis system effectively reduces waste products in the blood, improving patient outcomes in renal replacement therapy. The system's efficacy in optimizing dosing regimens for antibiotics in critically ill patients has also been explored.
Safety Profile
Reported complications include variable pharmacokinetics in critically ill patients receiving renal replacement therapy. However, specific adverse events directly related to the device are not detailed in the provided evidence.
Evidence Limitations
The evidence base is limited by a lack of comprehensive safety data and specific adverse event reporting. Further research is needed to explore long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for high efficiency hemodialysis system?
The device is indicated for use in patients requiring renal replacement therapy, such as those with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies have reported effective reduction of blood waste products and improved management of antibiotic dosing in renal replacement therapy.
What complications have been reported?
Safety data from evidence indicate variable pharmacokinetics in critically ill patients, but specific device-related complications are not detailed.
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.