📋 FDA Reference
Pack H Hemodialysis Urea Kinetic Modeling Software Program
Fresenius U
Summary: The Pack H Hemodialysis Urea Kinetic Modeling Software by Fresenius U is used to optimize dialysis treatment by modeling urea kinetics. It is primarily used by nephrologists and dialysis technicians to enhance patient care.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K955423 ↗
Decision Date ?
June 13, 1996
Product Code ?
FKP
Device Class ?
Class 2
Evidence ?
0 studies
The Pack H software was cleared through the FDA 510(k) pathway on June 13, 1996, by Fresenius U. It is classified as a Class 2 device under product code FKP.
What It Is
The Pack H Hemodialysis Urea Kinetic Modeling Software is a specialized program designed to assist in the management of hemodialysis treatment. It uses urea kinetic modeling to calculate and optimize dialysis dose, ensuring effective removal of waste products from the blood. This software supports clinicians in tailoring dialysis sessions to individual patient needs, improving treatment outcomes.
FDA-Cleared Indications
- For use in the calculation and assessment of hemodialysis treatment dose using urea kinetic modeling.
- For use by healthcare professionals managing patients undergoing hemodialysis.
Clinical Applications
- Calculating urea kinetic modeling results from hemodialysis treatment data.
- Assessing the delivered dose or adequacy of a hemodialysis treatment.
- Supporting clinical review of dialysis prescription and treatment performance.
- Assisting nephrology and dialysis staff in managing patients receiving maintenance hemodialysis.
Practical Considerations
- This is software rather than an implanted or disposable device, so it has no patient-contact size, catheter size, or vessel-access requirement.
- Results depend on accurate entry of treatment data, including relevant blood urea measurements, treatment duration, ultrafiltration information, and patient parameters.
- The software should be used by trained dialysis or nephrology personnel and interpreted alongside the patient's clinical condition and other laboratory results.
- Compatibility with dialysis equipment, data systems, and operating environments should be confirmed before implementation; the available FDA record does not establish compatibility with every dialysis machine.
- MRI safety labeling is generally not applicable to standalone clinical software, but any computer or hardware used with the program should be managed according to its own safety and facility policies.
Frequently Asked Questions
What is Pack H Hemodialysis Urea Kinetic Modeling Software used for?
It is used to optimize dialysis treatment by modeling urea kinetics, helping to calculate and adjust dialysis dosing for effective waste removal.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use this software in nephrology departments and dialysis centers.
What are the FDA-cleared indications?
The software is indicated for use in calculating dialysis dosing for patients undergoing hemodialysis, particularly those with chronic kidney disease.
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.