EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

Leading manufacturers include Hollister, Inc., Coloplast A/S and E. R. Squibb & Sons, Inc..

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 10, 2014
OSTOM-I ALERT
K140938
11 Health and Technologies, LLC
Gastroenterology & Urology · 182d
Cleared Dec 30, 1993
LAKE OSTOMY CARE SET
K922730
Lake Medical Products, Inc.
Gastroenterology & Urology · 573d
Cleared Dec 08, 1988
ODOR-END EMERGENCY CLEAN UP POWDER
K882878
Cdc Products Corp.
Gastroenterology & Urology · 150d
Cleared Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636
Coloplast A/S
Gastroenterology & Urology · 90d
Cleared May 20, 1988
EMERGENCY-CLEAN UP(TM) ECP
K880306
Cdc Products Corp.
Gastroenterology & Urology · 116d
Cleared Dec 29, 1987
COMBINATION NITE DRAINAGE UNIT
K872294
Arnold Technologies
Gastroenterology & Urology · 196d
Cleared Dec 03, 1987
'CATCH-IT' OR FECAL CONTAINMENT DEVICE
K873929
Midwest Medical Co.
Gastroenterology & Urology · 69d
Cleared Oct 13, 1987
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
K871526
Cox Family Laboratories, Inc.
Gastroenterology & Urology · 176d
Cleared Aug 12, 1987
OSTO-PURE
K871738
Clearchem Corp.
Gastroenterology & Urology · 99d
Cleared Jul 08, 1987
PALEX (R) OSTOMY
K871628
Industrias Palex C/O Dma Med-Chem Corp.
Gastroenterology & Urology · 72d
Cleared Apr 17, 1987
E-Z LOOP
K870577
John F. Greer Co., Inc.
Gastroenterology & Urology · 66d
Cleared Apr 10, 1987
EZ TAC FILTER
K870531
John F. Greer Co., Inc.
Gastroenterology & Urology · 63d
Cleared Apr 01, 1987
PERSONAL PUNCH
K870136
Arnold Technologies
Gastroenterology & Urology · 78d
Cleared Dec 04, 1986
ULTRA-GEL - #4083
K864189
John F. Greer Co., Inc.
Gastroenterology & Urology · 38d
Cleared Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
K862631
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Jun 16, 1986
COLOPLAST CONVEX RING
K861070
Coloplast A/S
Gastroenterology & Urology · 88d
Cleared Apr 16, 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 121d
Cleared Feb 24, 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726
Pfizer, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 04, 1986
DURAHESIVE WAFER WITH FLANGE
K855018
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 50d
Cleared Jan 14, 1986
CONFIDENT ODOR ELIMINATOR
K852471
Hallmark Industries, Inc.
Gastroenterology & Urology · 217d
Cleared Jun 27, 1985
OSTOMY BAGS URETHEROSTOMY
K851678
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
OSTOMY BAGS COLOSTOMY
K851679
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d

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 →