FDA product code · Gastroenterology and urology
Implant, Anti-Gastroesophageal Reflux
3 FDA decisions since 1979. 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 LEI 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 · LEI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEI
Too few LEI 510(k)s in any year since 2007 to give a median.
Recalls per year · LEI
No recall names LEI since 2007.
Adverse event reports per year · LEI
163in 2025
MAUDE reports naming product code LEI, 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 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 1 |
| 2013 | 5 | — | 0 | 32 |
| 2014 | 3 | — | 0 | 42 |
| 2015 | 4 | — | 0 | 57 |
| 2016 | 4 | — | 0 | 92 |
| 2017 | 1 | — | 0 | 133 |
| 2018 | 6 | — | 0 | 203 |
| 2019 | 2 | — | 0 | 280 |
| 2020 | 1 | — | 0 | 193 |
| 2021 | 0 | — | 0 | 263 |
| 2022 | 6 | — | 0 | 250 |
| 2023 | 2 | — | 0 | 246 |
| 2024 | 1 | — | 0 | 168 |
| 2025 | 1 | — | 0 | 163 |
| 2026 | 3 | — | 0 | — |
Planning a device in LEI? 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) Report