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Hemodialysis Concentrates Related Products
Inventory Supply
Summary: Hemodialysis concentrates are used in dialysis to remove waste from the blood. Key evidence highlights their role in managing chronic kidney disease. Studies explore vascular health impacts.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870979 ↗
Decision Date ?
June 3, 1987
Product Code ?
KPO
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis concentrates by Inventory Supply were cleared through the FDA 510k pathway on June 3, 1987. They are classified as Class 2 medical devices.
What It Is
Hemodialysis concentrates are solutions used in dialysis machines to facilitate the removal of waste products from the blood in patients with renal failure. They are critical in maintaining electrolyte balance and removing toxins.
FDA-Cleared Indications
- For use as dialysate concentrates with hemodialysis systems.
- For treatment of patients whose kidneys cannot adequately remove waste products and regulate fluid and electrolyte balance.
Clinical Applications
- Preparation of dialysate for maintenance hemodialysis.
- Use during hemodialysis for patients with chronic kidney disease or kidney failure.
- Support of electrolyte and acid-base management during a dialysis treatment.
- Use with compatible dialysis equipment according to the concentrate and machine labeling.
Evidence Summary
The available literature includes various study types such as RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2020 to 2025, providing insights into the clinical efficacy and safety of hemodialysis concentrates.
Reported Outcomes
Published studies report that hemodialysis concentrates are effective in managing electrolyte balance and waste removal in dialysis patients. Some studies highlight their role in reducing vascular calcification and improving cardiovascular health. The concentrates are also noted for their minimal impact on plasma glucose levels.
Safety Profile
Reported complications include potential vascular calcification linked to increased trimethylamine N-oxide levels in patients undergoing hemodialysis. Other safety concerns are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically focusing on the safety profile of hemodialysis concentrates. Further research is needed to explore the long-term cardiovascular impacts and potential adverse effects.
Practical Considerations
- Concentrates must be mixed or proportioned with the specified water and dialysis machine system; incorrect dilution can cause serious electrolyte or acid-base abnormalities.
- The concentrate formulation must be compatible with the dialysis prescription, including sodium, potassium, calcium, magnesium, bicarbonate or acetate, and glucose when present.
- Products should be stored, handled, and inspected according to labeling to prevent contamination, deterioration, or use after expiration.
- This is a dialysis fluid product rather than an implantable device, so MRI safety labeling is generally not the primary concern; the dialysis machine and other connected equipment require separate evaluation.
- Use requires a functioning hemodialysis system and trained clinical staff; the appropriate formulation is selected based on the patient's prescription and laboratory results.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrates?
Hemodialysis concentrates are indicated for use in patients requiring dialysis to manage chronic kidney disease or end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies report effective management of electrolyte balance and waste removal, with some evidence suggesting reduced vascular calcification and improved cardiovascular health.
What complications have been reported?
Safety data indicate potential vascular calcification associated with increased trimethylamine N-oxide levels in hemodialysis patients.
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.