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, Nxstage Medical, Inc. and Deka Research and Development.
FDA 510(k) Cleared Dialysate Concentrate For Hemodialysis (liquid Or Powder) Devices (Product Code KPO)
About Product Code KPO - Regulatory Context
510(k) Submission Activity
123 total 510(k) submissions under product code KPO since 1978, with 123 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under KPO have taken an average of 97 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
KPO devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →