FDA Product Code KPO: Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Under FDA product code KPO, dialysate concentrates for hemodialysis are cleared for the preparation of dialysis fluid used during renal replacement therapy.

These concentrated solutions are diluted with purified water to create the dialysate — the fluid that flows on the outside of the dialyzer membrane to remove waste products and correct electrolyte imbalances from the patient's blood during hemodialysis sessions.

KPO devices are Class II medical devices, regulated under 21 CFR 876.5820 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC, Baxter Healthcare Corp and Nipro Renal Solutions USA, Corp..