Cidex Dialyzer Disinfecting Solution
by Surgikos, Inc. 510(k)
Active
510(k) K822535
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822535 | Date30 Sep 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FKQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cidex Dialyzer Disinfecting Solution is a chemical disinfectant designed for use in the reprocessing of dialyzer systems. Classified as a System, Dialysate Delivery, Central Multiple Patient device, it is intended for high-level disinfection of reusable dialyzer components to ensure patient safety during hemodialysis procedures. This solution targets microbial contamination in medical equipment used in both gastroenterology and urology settings, adhering to regulatory standards for reprocessing in central multiple-patient systems.
Supplied as a liquid formulation, the Cidex Dialyzer Disinfecting Solution is intended for single-use applications in controlled clinical environments. It is regulated under FDA 510(k) clearance (K822535) and falls under product code FKQ, with a classification as a Class II device. The solution is not sterile and must be handled according to manufacturer guidelines to maintain efficacy and safety. Storage and use are governed by regulatory requirements outlined in 21 CFR 876.5820, ensuring compliance with reprocessing protocols for medical devices in hemodialysis applications.
Other devices from Surgikos, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Cidex Dialyzer Disinfecting Solution used for?
The Cidex Dialyzer Disinfecting Solution is specifically designed for high-level disinfection of reusable dialyzer components used in hemodialysis procedures. It targets microbial contamination in medical equipment, ensuring patient safety during treatment. This solution is intended for use in central multiple-patient systems, adhering to regulatory standards for reprocessing in both gastroenterology and urology settings.
How is the Cidex Dialyzer Disinfecting Solution supplied?
The solution is supplied as a liquid formulation. It is intended for single-use applications in controlled clinical environments, meaning each use requires a fresh application of the solution to maintain efficacy and safety. The non-sterile nature of the product requires careful handling as per manufacturer guidelines.
Is the Cidex Dialyzer Disinfecting Solution sterile?
No, the Cidex Dialyzer Disinfecting Solution is not sterile. It is a chemical disinfectant and must be handled according to the manufacturer’s instructions to ensure proper disinfection without compromising sterility of the equipment being processed. Sterility is not a feature of this product.
What regulatory approval does the Cidex Dialyzer Disinfecting Solution have?
The Cidex Dialyzer Disinfecting Solution holds FDA 510(k) clearance under the reference number K822535. It is classified as a Class II device and falls under product code FKQ, which categorizes it as a System, Dialysate Delivery, Central Multiple Patient device. Compliance with reprocessing protocols is governed by 21 CFR 876.5820.
What storage and handling guidelines apply to the Cidex Dialyzer Disinfecting Solution?
The solution must be stored and used in accordance with regulatory requirements outlined in 21 CFR 876.5820. Proper storage ensures the solution remains effective for its intended purpose. Since it is not sterile, handling should follow manufacturer guidelines to prevent contamination and maintain the integrity of the disinfection process. Always refer to the manufacturer’s instructions for specific storage conditions.