FDA Product Code KOC: Accessories, Blood Circuit, Hemodialysis
Leading manufacturers include NIKKISO CO., LTD..
FDA 510(k) Cleared Accessories, Blood Circuit, Hemodialysis Devices (Product Code KOC)
About Product Code KOC - Regulatory Context
510(k) Submission Activity
182 total 510(k) submissions under product code KOC since 1976, with 182 receiving FDA clearance (average review time: 105 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 KOC have taken an average of 281 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
KOC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →