FDA Product Code FKX: System, Peritoneal, Automatic Delivery
Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC, Byonyks Pvt, Ltd. and Simergent, LLC.
FDA 510(k) Cleared System, Peritoneal, Automatic Delivery Devices (Product Code FKX)
About Product Code FKX - Regulatory Context
510(k) Submission Activity
83 total 510(k) submissions under product code FKX since 1977, with 83 receiving FDA clearance (average review time: 106 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under FKX have taken an average of 211 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
FKX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →