FDA product code · Cardiovascular
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
2 FDA decisions since 2022. No recall names this code.
Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QSK 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 · QSK
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSK
Too few QSK 510(k)s in any year since 2007 to give a median.
Recalls per year · QSK
No recall names QSK since 2007.
Adverse event reports per year · QSK
171in 2025
MAUDE reports naming product code QSK, 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 | 4 | — | 0 | 11 |
| 2023 | 3 | — | 0 | 26 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 6 | — | 0 | 171 |
| 2026 | 5 | — | 0 | — |
Planning a device in QSK? 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