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hemodialysis concentrates and related products
P & A
Summary: Hemodialysis concentrates by P & A are used in dialysis treatment to aid in the removal of waste products from the blood. Key evidence highlights associations with healthcare costs and quality of life in hemodialysis patients.
FDA Clearance Information
Pathway
510K
Number
K893991 ↗
Decision Date
January 11, 1990
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemodialysis concentrates by P & A were cleared through the FDA 510(k) pathway on January 11, 1990. They are classified as Class 2 medical devices.
What It Is
Hemodialysis concentrates are solutions used in dialysis to facilitate the removal of waste products and excess fluids from the blood. They are essential in the management of patients with end-stage renal disease.
Clinical Applications
These concentrates are commonly used in clinical settings for patients undergoing hemodialysis, particularly those with chronic kidney disease requiring regular dialysis sessions.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and prospective studies, with publication years ranging from 2013 to 2025.
Reported Outcomes
Published studies report associations between hemodialysis and healthcare costs, as well as health-related quality of life in patients. Improvements in quality of life and management of renal-related conditions are noted.
Safety Profile
Reported complications include potential impacts on peritoneal dialysis efficiency and peritoneal fibrosis due to long-term exposure to high glucose concentrations in dialysis environments.
Evidence Limitations
The evidence is limited by the lack of studies specifically addressing the direct outcomes of hemodialysis concentrates. Further research is needed to explore long-term safety and efficacy in diverse populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrates?
Hemodialysis concentrates are indicated for use in dialysis treatment to remove waste products and excess fluids from the blood in patients with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies have reported associations with healthcare costs and quality of life improvements in hemodialysis patients.
What complications have been reported?
Safety data indicate potential complications such as peritoneal fibrosis and decreased dialysis efficiency due to high glucose exposure.
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.