đź“‹ FDA Reference
pediatric hemodialysis replacement pump segment
Organon Teknika
Summary: The pediatric hemodialysis replacement pump segment by Organon Teknika is a medical device used in dialysis procedures for children. It is typically utilized by nephrologists and pediatric specialists in hospital settings to manage renal failure in pediatric patients.
FDA Clearance Information
Pathway
510K
Number
K854084 ↗
Decision Date
November 8, 1985
Product Code
FKL
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on November 8, 1985, by Organon Teknika. It is classified as a Class 2 medical device under product code FKL.
What It Is
The pediatric hemodialysis replacement pump segment is a component of a dialysis system designed specifically for pediatric patients. It functions by facilitating the removal of waste products and excess fluids from the blood when the kidneys are not functioning adequately. The device is engineered to accommodate the smaller blood volume and flow rates typical in children, ensuring safe and effective dialysis treatment.
Clinical Applications
This device is commonly used in pediatric nephrology for children with acute or chronic kidney failure. It is employed in hospital settings, particularly in pediatric intensive care units or specialized dialysis centers. Nephrologists and pediatricians use this device to perform hemodialysis on young patients, ensuring that the procedure is tailored to their unique physiological needs.
Indications for Use
The device is indicated for use in pediatric patients requiring hemodialysis due to renal failure. It is suitable for children who need assistance with blood filtration when their kidneys are unable to perform this function adequately.
Practical Considerations
When using this device, clinicians should consider the appropriate sizing and compatibility with other dialysis equipment. It is crucial to ensure that the pump segment is calibrated for pediatric use, taking into account the lower blood flow rates and volumes typical in children.
Frequently Asked Questions
What is the pediatric hemodialysis replacement pump segment used for?
It is used for performing hemodialysis in pediatric patients with kidney failure, helping to remove waste products and excess fluids from their blood.
What specialties typically use this device?
Nephrologists and pediatric specialists, particularly those working in pediatric intensive care units or dialysis centers, typically use this device.
What are the FDA-cleared indications?
The device is indicated for pediatric patients who require hemodialysis due to renal failure, providing a means to filter their blood when their kidneys cannot.
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.