FDA product code · Gastroenterology and urology
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
2 FDA decisions since 2011. 1 recall names this code; it is not Class I.
Treatment of chronic fecal incontinence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QON 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 · QON
34in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QON
Too few QON 510(k)s in any year since 2007 to give a median.
Recalls per year · QON
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QON
2in 2025
MAUDE reports naming product code QON, 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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 22 | — | 0 | 0 |
| 2012 | 19 | — | 0 | 0 |
| 2013 | 17 | — | 0 | 0 |
| 2014 | 23 | — | 0 | 0 |
| 2015 | 20 | — | 0 | 0 |
| 2016 | 27 | — | 0 | 0 |
| 2017 | 27 | — | 0 | 0 |
| 2018 | 19 | — | 0 | 0 |
| 2019 | 25 | — | 0 | 0 |
| 2020 | 42 | — | 0 | 0 |
| 2021 | 34 | — | 0 | 0 |
| 2022 | 46 | — | 0 | 0 |
| 2023 | 31 | — | 0 | 2 |
| 2024 | 35 | — | 0 | 0 |
| 2025 | 34 | — | 0 | 2 |
| 2026 | 33 | — | 1 | — |
Planning a device in QON? 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 876.5270.