EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

Leading manufacturers include Coloplast Corp..

102
Total
102
Cleared
66d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 90d recently vs 66d historically

FDA 510(k) Cleared Collector, Ostomy Devices (Product Code EXB)

102 devices
1–24 of 102
Cleared Oct 06, 2025
Heylo™ System
K252140
Coloplast Corp.
Gastroenterology & Urology · 90d

About Product Code EXB - Regulatory Context

510(k) Submission Activity

102 total 510(k) submissions under product code EXB since 1976, with 102 receiving FDA clearance (average review time: 66 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 EXB have taken an average of 90 days to reach a decision - up from 66 days historically. Manufacturers should account for longer review timelines in current project planning.

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