FDA Product Code KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

High-flux dialysis has transformed the standard of care for patients with end-stage renal disease. FDA product code KDI covers high permeability dialyzers.

These devices use semipermeable membranes with large pore sizes to remove both small and larger uremic toxins from the blood during hemodialysis. High permeability dialyzers have largely replaced low-flux membranes due to their superior clearance of middle molecules linked to long-term complications.

KDI devices are Class II medical devices, regulated under 21 CFR 876.5860 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Nxstage Medical, Inc., Hospal Medical Corp. and Fresenius Medical Care Renal Therapies Group, LLC.