FDA Product Code KDL: Set, Perfusion, Kidney, Disposable
Leading manufacturers include Institut Georges Lopez, Bridge TO Life, Ltd. and S.A.L.F. Spa.
FDA 510(k) Cleared Set, Perfusion, Kidney, Disposable Devices (Product Code KDL)
About Product Code KDL - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code KDL since 1976, with 19 receiving FDA clearance (average review time: 231 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under KDL have taken an average of 266 days to reach a decision - up from 229 days historically. Manufacturers should account for longer review timelines in current project planning.
KDL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →