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 Fresenius Medical Care Renal Therapies Group, LLC, Baxter Healthcare Corporation and Nxstage Medical, Inc..
List of Dialyzer, High Permeability With Or Without Sealed Dialysate System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Dialyzer, High Permeability With Or Without Sealed Dialysate System devices (product code KDI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →