Identifiers
- 510(k) Number
- K160847 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 CitraPure Acid Concentrate is a Dialysate Concentrate for Hemodialysis (Liquid or Powder), designed to provide citric acid-based electrolyte solutions for hemodialysis treatment. It is formulated to support acidification in the dialysate process, ensuring proper electrolyte balance during acute and chronic hemodialysis procedures.
This product is supplied as a powder or liquid concentrate and is intended for use exclusively with compatible bicarbonate concentrates (e.g., RenalPure Powder Bicarbonate or SteriLyte Liquid Bicarbonate) in a 45X three-stream hemodialysis machine. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5820) and has received FDA 510(k) clearance (K160847) as substantially equivalent to a predicate device. Sterility and single-use or reusable status are not specified in the provided data.
Frequently asked questions
What types of hemodialysis treatments is the CitraPure Acid Concentrate designed to support, and how does it differ from standard acid concentrates?
The CitraPure Acid Concentrate is specifically formulated to provide citric acid-based electrolyte solutions for both acute and chronic hemodialysis procedures. Unlike traditional acid concentrates, it is designed to support acidification in the dialysate process using citric acid, which may help maintain proper electrolyte balance during dialysis. It is intended for use exclusively with compatible bicarbonate concentrates in a 45X three-stream hemodialysis machine, ensuring precise electrolyte adjustments tailored to patient needs.
Is the CitraPure Acid Concentrate available in liquid or powder form, and how does this affect its handling or storage requirements?
The CitraPure Acid Concentrate is supplied as either a powder or liquid concentrate, offering flexibility in handling depending on clinical preferences or facility infrastructure. The powder form may be easier to store in dry environments, reducing the risk of contamination, while the liquid form allows for immediate use without reconstitution. Both forms require adherence to standard medical device storage guidelines to maintain integrity, though specific sterility or shelf-life details are not provided in the data.
Can this product be used with any bicarbonate concentrate, or are there specific brands or types it requires for compatibility?
The CitraPure Acid Concentrate is designed for exclusive use with compatible bicarbonate concentrates, such as Rockwell Medical’s RenalPure Powder Bicarbonate or SteriLyte Liquid Bicarbonate. It is not intended for use with all bicarbonate concentrates, so verifying compatibility with the specific brand and type is critical to ensure proper dialysate formulation and patient safety during hemodialysis.
How is the regulatory status of the CitraPure Acid Concentrate determined, and what does the FDA 510(k) clearance indicate about its safety and effectiveness?
The CitraPure Acid Concentrate holds FDA 510(k) clearance (K160847), meaning it has been deemed *substantially equivalent* to a predicate device already on the market. This clearance indicates that the FDA has reviewed its design, manufacturing processes, and performance data to confirm it meets regulatory standards for safety, effectiveness, and performance. The classification as a Class II medical device (21 CFR 876.5820) reflects its moderate risk level, requiring compliance with specific controls to ensure quality and reliability.
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: Hemodialysis Products | Rockwell Medical, PDF Hemodialysis Concentrates - Rockwell Medical, Rockwell Medical CitraPure Acid Concetrate (K160847) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160847 | Class II | Active |
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Manufacturer
- Manufacturer
- Rockwell Medical
Sources (1)
- FDA 510(k) K160847 24 fields · synced Oct 6, 2026