KOB · Class II · 21 CFR 876.5090

FDA Product Code KOB: Catheter, Suprapubic (and Accessories)

Leading manufacturers include Applied Medical Technology, Inc..

32
Total
32
Cleared
98d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 253d recently vs 93d historically

FDA 510(k) Cleared Catheter, Suprapubic (and Accessories) Devices (Product Code KOB)

32 devices
1–24 of 32
Cleared Nov 01, 2024
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514
Applied Medical Technology, Inc.
Gastroenterology & Urology · 253d

About Product Code KOB - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code KOB since 1978, with 32 receiving FDA clearance (average review time: 98 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under KOB have taken an average of 253 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.

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