FDA product code · Cardiovascular
Prosthesis, Mitral Valve, Percutaneously Delivered
2 FDA decisions since 2024. No recall names this code.
These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NPU 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 · NPU
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NPU
Too few NPU 510(k)s in any year since 2007 to give a median.
Recalls per year · NPU
No recall names NPU since 2007.
Adverse event reports per year · NPU
312in 2025
MAUDE reports naming product code NPU, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 51 |
| 2019 | 0 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 218 |
| 2021 | 0 | — | 0 | 248 |
| 2022 | 0 | — | 0 | 213 |
| 2023 | 0 | — | 0 | 288 |
| 2024 | 1 | — | 0 | 280 |
| 2025 | 4 | — | 0 | 312 |
| 2026 | 7 | — | 0 | — |
Planning a device in NPU? 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