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hemodialysis apparatus
Heald Manufacturing
Summary: The hemodialysis apparatus by Heald Manufacturing is used for renal replacement therapy in patients with kidney failure. Key evidence highlights its role in waste management and monitoring of serum components during dialysis.
FDA Clearance Information
Pathway
510K
Number
K772161 ↗
Decision Date
January 3, 1978
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The hemodialysis apparatus by Heald Manufacturing was cleared through the FDA 510k pathway on January 3, 1978. It is classified as a Class 2 device under product code FKQ.
What It Is
The hemodialysis apparatus is a medical device designed to perform dialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It is primarily used in patients with end-stage renal disease.
Clinical Applications
This device is commonly used in clinical settings for patients requiring renal replacement therapy due to chronic kidney failure. It is essential in managing electrolyte balance and removing toxins from the bloodstream.
Evidence Summary
The available literature includes 15 studies, with a range of study types such as RCTs and prospective studies, spanning from 1998 to 2025. These studies explore various aspects of hemodialysis, including waste management and serum monitoring.
Reported Outcomes
Published studies report that the hemodialysis apparatus effectively reduces waste mass in dialysis circuits and aids in the measurement of serum components like L-amino acids. These findings support its role in improving dialysis efficiency and patient monitoring.
Safety Profile
Reported complications include the influence of hemodialysis membranes on serum beta-glucan levels, which may affect the diagnosis of certain conditions. No other significant adverse events were detailed in the provided studies.
Evidence Limitations
The evidence highlights gaps in standardized protocols for waste management and the need for further research on the long-term effects of hemodialysis on serum components. Additional studies are required to validate these findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis apparatus?
The device is indicated for use in patients with end-stage renal disease requiring dialysis to remove waste products and excess fluid from the blood.
What outcomes have been reported in clinical studies?
Studies have reported effective waste reduction in dialysis circuits and accurate monitoring of serum L-amino acids during hemodialysis.
What complications have been reported?
Safety data indicate potential alterations in serum beta-glucan levels due to hemodialysis membranes, which may impact certain diagnostic processes.
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.