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 Outset Medical, Inc..
FDA 510(k) Cleared Dialyzer, High Permeability With Or Without Sealed Dialysate System Devices (Product Code KDI)
About Product Code KDI - Regulatory Context
510(k) Submission Activity
343 total 510(k) submissions under product code KDI since 1978, with 343 receiving FDA clearance (average review time: 176 days).
Submission volume has remained relatively stable over the observed period, with 15 submissions in the last 24 months.
FDA Review Time
FDA review times for KDI submissions have been consistent, averaging 178 days recently vs 176 days historically.
KDI devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →