95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers

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

510(k) Number

K974090 ↗

FDA Product Code

MSE

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fresenius Medical Care North America →

• What is the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS used for?

  This device is a reprocessing system designed to clean and sterilize polysulfone hemodialyzers for multiple patient use using a citric acid-based heat process. It enables safe reuse of dialyzers in hemodialysis treatments where reuse protocols are followed, reducing waste and cost while maintaining performance through validated cleaning and disinfection steps.

• Is the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS sterile or single-use?

  No, this device is not sterile and is not intended for single-use. It is a reprocessing aid used to clean and sterilize dialyzers between patient uses. The system itself is reused as part of a validated reprocessing workflow, and the dialyzers it processes are intended for multiple applications after proper cleaning and disinfection.

• How is the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS supplied and what are its key specifications?

  The device is supplied as a processing method or system for cleaning and sterilizing dialyzers, not as a physical implant or disposable component. It operates using a citric acid solution heated to 95°C with a 1.5% concentration, as indicated in its name. It is classified as a Class II medical device under regulation 876.5820 with product code MSE and received FDA 510(k) clearance under K974090.