Typhoon Bicarb Mixing and Distribution System
510(k) K060333
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060333 | Date8 Sep 2006 | 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- Withdrawn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
- Full name
- Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System
- 510(k) Number
- FDA Product Code
- FIN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Typhoon Bicarb Mixing and Distribution System is a Tank, Holding, Dialysis device designed for the preparation and distribution of bicarbonate solutions in hemodialysis. It automates the mixing process to ensure precise formulation of dialysis fluids, maintaining consistent chemical composition for patient treatment. The system integrates with hemodialysis circuits to deliver accurate bicarbonate concentrations, supporting renal replacement therapy protocols. Its design aligns with regulatory standards for dialysis fluid preparation, emphasizing safety and reliability in clinical settings.
This system is supplied as a reusable medical device, intended for use in dialysis centers and renal care facilities. It operates under sterile conditions during preparation and distribution, adhering to FDA Class II regulatory requirements (21 CFR 876.5820). The device is authorized via FDA 510(k) clearance (K060333), demonstrating substantial equivalence to predicate bicarbonate mixing systems. Storage and maintenance protocols must follow manufacturer guidelines to preserve functionality, with no specific MRI safety considerations noted in the regulatory data.
Other devices from Dialysis Services, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical setting is the Typhoon Bicarb Mixing and Distribution System intended for use in?
The Typhoon Bicarb Mixing and Distribution System is designed specifically for dialysis centers and renal care facilities. It automates the preparation and distribution of bicarbonate solutions used in hemodialysis, ensuring precise formulation of dialysis fluids for renal replacement therapy.
Is the Typhoon Bicarb Mixing and Distribution System a single-use or reusable device?
The Typhoon Bicarb Mixing and Distribution System is a reusable medical device. It is intended for repeated use in clinical settings, provided it is properly maintained and stored according to the manufacturer’s guidelines to ensure functionality and safety.
How does the Typhoon Bicarb Mixing and Distribution System ensure sterile conditions during operation?
The system adheres to sterile conditions during the preparation and distribution of bicarbonate solutions, as outlined in its design and regulatory compliance. While the device itself is reusable, the sterile handling of fluids is critical, and the manufacturer’s protocols must be followed to maintain sterility throughout use.
What regulatory pathway was followed for FDA clearance of the Typhoon Bicarb Mixing and Distribution System?
The Typhoon Bicarb Mixing and Distribution System received FDA clearance through a 510(k) submission (K060333), demonstrating substantial equivalence to a predicate bicarbonate mixing system. The clearance falls under FDA Class II (21 CFR 876.5820) for Tank, Holding, Dialysis devices, with a traditional review process.
Are there any special storage requirements for the Typhoon Bicarb Mixing and Distribution System?
The system requires adherence to the manufacturer’s storage and maintenance protocols to preserve functionality. While no specific MRI safety considerations are noted, proper cleaning, calibration, and environmental conditions (e.g., temperature, humidity) are essential to ensure reliable performance and compliance with regulatory standards.