FDA product code · Gastroenterology and urology
Gastrointestinal Motility System, Capsule
5 FDA decisions since 2006. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 90 and 90). No recall names this code. The most-cited predicate is K092342, named by 2 later devices.
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NYV 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 · NYV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NYV
Too few NYV 510(k)s in any year since 2007 to give a median.
Recalls per year · NYV
No recall names NYV since 2007.
Adverse event reports per year · NYV
1in 2025
MAUDE reports naming product code NYV, 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 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
Planning a device in NYV? 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 876.1725.