FDA product code · Cardiovascular
Aortic Stent
2 FDA decisions since 2016. No recall names this code.
Coarctation of the Aorta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PNF 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 · PNF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNF
Too few PNF 510(k)s in any year since 2007 to give a median.
Recalls per year · PNF
No recall names PNF since 2007.
Adverse event reports per year · PNF
9in 2025
MAUDE reports naming product code PNF, 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 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 4 | — | 0 | 9 |
| 2026 | 4 | — | 0 | — |
Planning a device in PNF? 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