KOD · Class II · 21 CFR 876.5130

FDA Product Code KOD: Catheter, Urological

Leading manufacturers include C.R. Bard, Inc..

238
Total
238
Cleared
90d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 251d recently vs 89d historically

FDA 510(k) Cleared Catheter, Urological Devices (Product Code KOD)

238 devices
1–24 of 238
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864
C.R. Bard, Inc.
Gastroenterology & Urology · 251d

About Product Code KOD - Regulatory Context

510(k) Submission Activity

238 total 510(k) submissions under product code KOD since 1976, with 238 receiving FDA clearance (average review time: 90 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 KOD have taken an average of 251 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.

KOD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →