EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

Leading manufacturers include Howmedica Corp., C.R. Bard, Inc. and 11 Health Technologies Limited.

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
Cleared Nov 16, 2018
SmartBag (SmartPouch)
K181643
11 Health Technologies Limited
Gastroenterology & Urology · 147d
Cleared Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
K862631
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared May 23, 1985
BARD PERISTOMAL PASTE
K851398
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared Nov 29, 1984
UNITED SKIN BARRIERS
K844046
Howmedica Corp.
Gastroenterology & Urology · 43d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029
Howmedica Corp.
Gastroenterology & Urology · 23d
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Jul 02, 1982
BARD PROTECTIVE BARRIER FILM
K821271
C.R. Bard, Inc.
Gastroenterology & Urology · 60d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080
Howmedica Corp.
Gastroenterology & Urology · 15d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared Jul 28, 1980
SUPER BANISH DEODORANT
K801471
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Dec 10, 1979
BONGORT ODOR BARRIER DRAIN
K792381
Howmedica Corp.
Gastroenterology & Urology · 14d
Cleared Nov 13, 1979
FEATHER-LITE URINARY DIV. POUCH
K792139
Howmedica Corp.
Gastroenterology & Urology · 22d
Cleared Oct 02, 1979
COLOPLAST CARBON GAS FILTER
K791581
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Sep 30, 1977
COLORPLAST TRANSVERSE SYSTEM
K771775
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Dec 02, 1976
BONGORT ILEOSTOMY POUCH
K760878
Howmedica Corp.
Gastroenterology & Urology · 42d
Cleared Oct 15, 1976
BONGORT SPECIAL ODORPROOF DRAIN
K760735
Howmedica Corp.
Gastroenterology & Urology · 17d

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 510(k) Review Time - EXB Product Code

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 →