FDA product code · Cardiovascular
Pulmonary Valve Prosthesis Percutaneously Delivered
3 FDA decisions since 2015. 2 recalls name this code, 2 of them Class I.
These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously 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 NPV 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 · NPV
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPV
Too few NPV 510(k)s in any year since 2007 to give a median.
Recalls per year · NPV
1in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NPV
329in 2025
MAUDE reports naming product code NPV, 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 | 20 |
| 2011 | 0 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 36 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 72 |
| 2016 | 3 | — | 0 | 66 |
| 2017 | 5 | — | 0 | 96 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 4 | — | 0 | 143 |
| 2020 | 7 | — | 0 | 112 |
| 2021 | 16 | — | 0 | 153 |
| 2022 | 26 | — | 1 (1) | 191 |
| 2023 | 36 | — | 0 | 253 |
| 2024 | 19 | — | 0 | 325 |
| 2025 | 22 | — | 0 | 329 |
| 2026 | 24 | — | 1 (1) | — |
Planning a device in NPV? 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