FDA product code · Cardiovascular
Transcatheter Septal Occluder
5 FDA decisions since 2001. 13 recalls name this code, 0 of them Class I.
Approved PMA: P000039
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MLV 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 · MLV
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLV
Too few MLV 510(k)s in any year since 2007 to give a median.
Recalls per year · MLV
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLV
766in 2025
MAUDE reports naming product code MLV, 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 | 5 | — | 0 | 103 |
| 2008 | 9 | — | 0 | 178 |
| 2009 | 11 | — | 0 | 187 |
| 2010 | 6 | — | 0 | 186 |
| 2011 | 13 | — | 0 | 201 |
| 2012 | 9 | — | 0 | 189 |
| 2013 | 5 | — | 0 | 134 |
| 2014 | 7 | — | 0 | 103 |
| 2015 | 5 | — | 0 | 133 |
| 2016 | 17 | — | 0 | 123 |
| 2017 | 13 | — | 0 | 140 |
| 2018 | 14 | — | 0 | 212 |
| 2019 | 27 | — | 0 | 406 |
| 2020 | 21 | — | 0 | 407 |
| 2021 | 14 | — | 9 | 487 |
| 2022 | 11 | — | 2 | 504 |
| 2023 | 3 | — | 0 | 672 |
| 2024 | 16 | — | 0 | 843 |
| 2025 | 8 | — | 0 | 766 |
| 2026 | 6 | — | 0 | — |
Planning a device in MLV? 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