FDA product code · Cardiovascular
Aortic Valve, Prosthesis, Percutaneously Delivered
8 FDA decisions since 2011. 23 recalls name this code, 10 of them Class I.
To replace a patient's aortic 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 NPT 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 · NPT
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPT
Too few NPT 510(k)s in any year since 2007 to give a median.
Recalls per year · NPT
5in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · NPT
12,906in 2025
MAUDE reports naming product code NPT, 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 | 1 | — | 0 | 0 |
| 2012 | 20 | — | 0 | 98 |
| 2013 | 48 | — | 0 | 1,096 |
| 2014 | 56 | — | 4 (3) | 2,161 |
| 2015 | 43 | — | 0 | 2,862 |
| 2016 | 61 | — | 0 | 2,996 |
| 2017 | 65 | — | 1 (1) | 3,115 |
| 2018 | 43 | — | 0 | 3,916 |
| 2019 | 59 | — | 1 | 4,361 |
| 2020 | 48 | — | 9 (6) | 5,806 |
| 2021 | 42 | — | 0 | 5,604 |
| 2022 | 41 | — | 0 | 5,994 |
| 2023 | 49 | — | 0 | 8,319 |
| 2024 | 33 | — | 5 | 11,043 |
| 2025 | 29 | — | 0 | 12,906 |
| 2026 | 34 | — | 3 | — |
Planning a device in NPT? 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