FDA Product Code KDN: System, Perfusion, Kidney

510(k) Submission Activity

42 total 510(k) submissions under product code KDN since 1983, with 42 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for KDN submissions have been consistent, averaging 165 days recently vs 179 days historically.