FDA product code · Cardiovascular
System, Appendage Closure, Left Atrial
2 FDA decisions since 2015. 1 recall names this code; it is not 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 NGV 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 · NGV
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGV
Too few NGV 510(k)s in any year since 2007 to give a median.
Recalls per year · NGV
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGV
2,822in 2025
MAUDE reports naming product code NGV, 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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 4 | — | 0 | 286 |
| 2016 | 8 | — | 0 | 621 |
| 2017 | 5 | — | 0 | 1,022 |
| 2018 | 6 | — | 0 | 1,019 |
| 2019 | 10 | — | 0 | 996 |
| 2020 | 5 | — | 0 | 935 |
| 2021 | 10 | — | 0 | 1,175 |
| 2022 | 9 | — | 0 | 1,493 |
| 2023 | 10 | — | 0 | 2,429 |
| 2024 | 11 | — | 0 | 2,698 |
| 2025 | 15 | — | 0 | 2,822 |
| 2026 | 12 | — | 1 | — |
Planning a device in NGV? 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