FDA product code · Cardiovascular
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
1 FDA decision since 2024. No recall names this code.
Endovascular repair of thoracoabdominal and pararenal aortic lesions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QZK 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 · QZK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZK
Too few QZK 510(k)s in any year since 2007 to give a median.
Recalls per year · QZK
No recall names QZK since 2007.
Adverse event reports per year · QZK
68in 2025
MAUDE reports naming product code QZK, 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 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 6 | — | 0 | 16 |
| 2025 | 4 | — | 0 | 68 |
| 2026 | 3 | — | 0 | — |
Planning a device in QZK? 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