Recommended Alternative Dialyzer Disinfectant

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K852749 ↗

FDA Product Code

FKQ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Warexin Recommended Alternative Dialyz

  Class II

  FDA 510(k) K843520 Active Cleared 4 Oct 1984

• Model 90DX Multitest Meter

  Class II

  FDA 510(k) K882032 Active Cleared 11 Aug 1988

• Model 102 Ph Meter

  Class II

  FDA 510(k) K870811 Active Cleared 24 Mar 1987

• Echo, Model Mm-1000

  Class II

  FDA 510(k) K821383 Active Cleared 23 Jun 1982

• Echo MM1000

  Class II

  FDA 510(k) K834447 Active Cleared 23 Mar 1984

• 90DX Multitest Meter, Modification

  Class II

  FDA 510(k) K925210 Active Cleared 25 Jan 1994

• What is the primary purpose of the Recommended Alternative Dialyzer Disinfectant in a hemodialysis facility?

  This disinfectant is specifically designed to decontaminate dialyzer membranes and associated components between patient use cycles. Its purpose is to reduce the risk of cross-contamination by eliminating pathogens that could persist on the equipment after use, ensuring safer reprocessing for subsequent patients.

• How is the Recommended Alternative Dialyzer Disinfectant supplied, and can it be used with automated systems?

  The product is supplied as a liquid solution, which can be applied manually or integrated into automated reprocessing protocols in dialysis facilities. Its formulation supports both methods, making it versatile for different facility workflows.

• Is the Recommended Alternative Dialyzer Disinfectant intended for single-use or repeated use in reprocessing?

  The device is not labeled as single-use or reusable, but it is explicitly intended for repeated use in reprocessing protocols. Facilities should follow the manufacturer’s guidelines for chemical stability and storage to ensure safe and effective disinfection across multiple cycles.

• What regulatory pathway does the Recommended Alternative Dialyzer Disinfectant follow, and what does this mean for its use?

  The device is cleared under the FDA’s 510(k) pathway (K852749) and classified as a Class II medical device. This means it has undergone review to demonstrate substantial equivalence to a predicate device and meets regulatory standards for disinfectants in renal care, ensuring its safety and effectiveness for reprocessing dialyzers.

• Are there specific storage requirements mentioned for the Recommended Alternative Dialyzer Disinfectant?

  While the exact storage conditions are not detailed in the provided data, the manufacturer specifies that storage requirements must be followed to maintain the chemical stability of the disinfectant. Facilities should consult the product documentation for precise guidelines on temperature, light exposure, and shelf life.