FDA product code · Gastroenterology and urology
Implant, Intragastric For Morbid Obesity
8 FDA decisions since 1985. 22 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LTI 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 · LTI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTI
Too few LTI 510(k)s in any year since 2007 to give a median.
Recalls per year · LTI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTI
295in 2025
MAUDE reports naming product code LTI, 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 | 2 | — | 0 | 587 |
| 2008 | 5 | — | 0 | 1,357 |
| 2009 | 4 | — | 0 | 1,365 |
| 2010 | 7 | — | 17 | 1,461 |
| 2011 | 10 | — | 1 | 1,347 |
| 2012 | 1 | — | 0 | 1,383 |
| 2013 | 2 | — | 3 | 920 |
| 2014 | 3 | — | 0 | 563 |
| 2015 | 6 | — | 0 | 560 |
| 2016 | 14 | — | 1 | 514 |
| 2017 | 14 | — | 0 | 528 |
| 2018 | 32 | — | 0 | 453 |
| 2019 | 21 | — | 0 | 334 |
| 2020 | 5 | — | 0 | 165 |
| 2021 | 3 | — | 0 | 193 |
| 2022 | 2 | — | 0 | 609 |
| 2023 | 4 | — | 0 | 975 |
| 2024 | 4 | — | 0 | 451 |
| 2025 | 2 | — | 0 | 295 |
| 2026 | 4 | — | 0 | — |
Planning a device in LTI? 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