Nikkicart
by Renal Care Dialysis Solutions, S.A. DE C.V.
510(k) K221652
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221652 | Date3 Mar 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPO
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Nikkicart Dialysate Concentrate Cartridge is a Dialysate Concentrate for Hemodialysis (Liquid or Powder) designed to prepare bicarbonate-based dialysate for extracorporeal hemodialysis. It functions as a key component in generating hemodialysis fluid by combining with water and acid concentrates in a 3-stream proportioning system, enabling treatment for acute or chronic renal failure or acute intoxication with dialyzable substances.
This device is intended for single-use in clinical settings equipped with compatible hemodialysis machines, such as the Nikkiso DBB system. Supplied sterile and packaged for medical use, it adheres to FDA 510(k) clearance (K221652) under regulation 876.5820, classified as a Class II medical device. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Other devices from Renal Care Dialysis Solutions, S.A. DE C.V.
Questions
AI-generated answers, 19 Sep 2026
What types of dialysis treatments can the Nikkicart Dialysate Concentrate Cartridge be used for, and how does it integrate with dialysis machines?
The Nikkicart Dialysate Concentrate Cartridge is designed specifically for preparing bicarbonate-based dialysate used in extracorporeal hemodialysis. It is intended for treating patients with acute or chronic renal failure as well as cases of acute intoxication with dialyzable substances. It works within a 3-stream proportioning system, combining with water and acid concentrates to generate the dialysis fluid. It is compatible only with hemodialysis machines like the Nikkiso DBB system, ensuring proper integration for clinical use.
Is the Nikkicart Dialysate Concentrate Cartridge meant for single-use or can it be reused?
The Nikkicart Dialysate Concentrate Cartridge is explicitly designed for single-use only in clinical settings. This ensures sterility and safety for patient treatment, as reuse could compromise its integrity and potentially introduce contamination risks. Always follow manufacturer guidelines to maintain proper handling and sterility.
What storage and handling precautions should be taken to ensure the cartridge remains effective?
The Nikkicart Dialysate Concentrate Cartridge is supplied sterile and packaged for medical use, so storage must comply with manufacturer instructions to preserve sterility and functionality. Proper handling—including avoiding contamination, extreme temperatures, and improper storage conditions—is critical. Adhering to these guidelines ensures the cartridge remains suitable for its intended use in hemodialysis.
What regulatory pathway was followed for the FDA clearance of the Nikkicart Dialysate Concentrate Cartridge?
The Nikkicart Dialysate Concentrate Cartridge received FDA 510(k) clearance (K221652) under the Traditional 510(k) pathway, classified as a Class II medical device under regulation 876.5820. The submission was determined substantially equivalent to a predicate device, and the decision was reviewed by the Gastroenterology and Urology (GU) Advisory Committee. This clearance confirms its compliance with U.S. safety and performance standards for hemodialysis concentrates.