FDA product code · Gastroenterology and urology
Bag, Urinary, Ileostomy
FDA lists EXH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of EXH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · EXH
FDA has decided no EXH device since 2007.
Median 510(k) review, days · EXH
Too few EXH 510(k)s in any year since 2007 to give a median.
Recalls per year · EXH
No recall names EXH since 2007.
Adverse event reports per year · EXH
13in 2025
MAUDE reports naming product code EXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 88 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 112 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 0 | 89 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 59 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
Planning a device in EXH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 876.5900.