FDA product code EXB: Collector, Ostomy
EXB is the FDA product code for collector, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 102 510(k) submissions under EXB, 1 in the last five years, from 36 different applicants. The average 510(k) review took 66 days (median 49); 90 days on average over the last three years. FDA has posted 5 recalls for EXB devices.
Classification
| Field | Value |
|---|---|
| Device name | Collector, Ostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EXB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 147 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every EXB clearance
Top EXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 14 | 1982-06-24 |
| Coloplast A/S | 11 | 1988-07-13 |
| E. R. Squibb & Sons, Inc. | 10 | 1981-06-16 |
| Convatec, A Division of E.R. Squibb & Sons | 9 | 1986-04-16 |
| Howmedica Corp. | 9 | 1984-11-29 |
31 more applicants have EXB clearances. See the full list in Caduvo.
Most recent EXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252140 | Coloplast Corp. | Heylo System | 2025-10-06 | 90 |
| K181643 | 11 Health Technologies Limited | SmartBag (SmartPouch) | 2018-11-16 | 147 |
| K140938 | 11 Health and Technologies, LLC | OSTOM-I ALERT | 2014-10-10 | 182 |
| K922730 | Lake Medical Products, Inc. | LAKE OSTOMY CARE SET | 1993-12-30 | 573 |
| K882878 | Cdc Products Corp. | ODOR-END EMERGENCY CLEAN UP POWDER | 1988-12-08 | 150 |
Recalls for EXB devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-07-27.
Frequently asked questions
What is FDA product code EXB?
EXB is the FDA product code for collector, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EXB?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXB?
Across 102 cleared submissions the average was 66 days from receipt to decision (median 49).
Which companies have the most EXB clearances?
Hollister, Inc. (14); Coloplast A/S (11); E. R. Squibb & Sons, Inc. (10); Convatec, A Division of E.R. Squibb & Sons (9); Howmedica Corp. (9).
Have EXB devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2011-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code EXB
- Run a recall and safety report across every EXB manufacturer
- Watch product code EXB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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