📋 FDA Reference
Rockwell Medical Supply Llc Hemodialysis Concentrate Solutions Powders
Rockwell Medical Supply
Summary: Hemodialysis concentrate solutions powders are used in dialysis to help filter waste from the blood. They are primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K954527 ↗
Decision Date ?
March 1, 1996
Product Code ?
KPO
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on March 1, 1996, by Rockwell Medical Supply. It is classified as a Class 2 medical device under product code KPO.
What It Is
Hemodialysis concentrate solutions powders are essential components in the dialysis process. They are mixed with purified water to create a dialysate solution, which helps remove waste products and excess fluid from the blood of patients with kidney failure. This device is crucial for maintaining the electrolyte balance and overall stability of patients undergoing hemodialysis.
FDA-Cleared Indications
- For use in preparing dialysate for hemodialysis treatment.
- For treatment of patients whose kidneys cannot adequately remove waste products and excess fluid from the blood.
Clinical Applications
- Preparing dialysate in outpatient hemodialysis centers.
- Preparing dialysate for hemodialysis performed in hospitals.
- Supporting routine hemodialysis treatment for patients with advanced or end-stage kidney failure.
- Providing the electrolyte-containing dialysis fluid used to exchange solutes and remove excess fluid during hemodialysis.
Practical Considerations
- The powder must be mixed with the specified volume and quality of purified water according to the product labeling and dialysis-unit protocol.
- The resulting concentrate or dialysate must be compatible with the dialysis machine and the prescribed treatment system.
- Dialysate composition, including electrolytes and buffering agents, should match the patient's prescription and clinical needs.
- These powders are not administered directly to a patient; incorrect concentration, contamination, or improper handling can cause serious harm.
- The product is not an implant or an MRI device, so MRI safety labeling is generally not applicable; it should be kept outside the MRI environment according to institutional safety procedures.
Frequently Asked Questions
What is hemodialysis concentrate solutions powders used for?
It is used to create a dialysate solution that helps filter waste and excess fluid from the blood during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis treatment for patients with kidney failure to assist in blood filtration.
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.