PrismaSATE Dialysate Concentrate for Hemodialysis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013448 FDA 510(k)
- FDA Product Code
- KPO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PrismaSATE Dialysate Concentrate is a liquid or powder formulation designed as a dialysate concentrate for hemodialysis. Classified under FDA regulation 876.5820, it is intended for use in continuous renal replacement therapies, including continuous hemodialysis and hemodiafiltration, to normalize blood composition in patients with acute kidney disease. This concentrate is part of a system requiring further preparation before clinical use.
Supplied as a sterile, ready-to-use concentrate, the PrismaSATE is packaged for use in commercially available Continuous Renal Replacement Therapy (CRRT) machines. It is classified as a Class II medical device under FDA 510(k) clearance (K013448) and is intended for single-use applications. The device adheres to regulatory standards for hemodialysis concentrates and is intended for prescription by healthcare providers to match specific patient treatment needs.
Frequently asked questions
What is the PrismaSATE Dialysate Concentrate used for?
The PrismaSATE Dialysate Concentrate is designed to normalize blood composition in patients with acute kidney disease by serving as a concentrate for hemodialysis. It is specifically intended for use in continuous renal replacement therapies, including continuous hemodialysis and hemodiafiltration, as part of a system requiring further preparation before clinical use.
How is the PrismaSATE Dialysate Concentrate supplied?
The PrismaSATE is supplied as a sterile, ready-to-use concentrate. It is packaged for use in commercially available Continuous Renal Replacement Therapy (CRRT) machines, ensuring compatibility with these systems.
Is the PrismaSATE Dialysate Concentrate intended for single-use or reuse?
The PrismaSATE Dialysate Concentrate is classified as a single-use device. This classification ensures patient safety by preventing contamination and maintaining sterility between uses.
What types of CRRT machines can the PrismaSATE be used with?
The PrismaSATE is designed to be used with commercially available Continuous Renal Replacement Therapy (CRRT) machines. While the exact models are not specified, its packaging and regulatory classification ensure compatibility with standard CRRT systems.
How should the PrismaSATE Dialysate Concentrate be stored?
While specific storage instructions are not detailed in the provided data, sterile medical devices like the PrismaSATE Dialysate Concentrate should generally be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Always follow the manufacturer’s guidelines, which may be included in the packaging or accompanying documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gambro Renal Products Catalog - Supplies Distributor - CIA Medical, PrismaSATE Dialysis Solution - Medline, Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013448 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro Renal Products
Sources (1)
- FDA 510(k) K013448 24 fields · synced Oct 1, 2026