FDA product code · Cardiovascular
Stent, Central Venous
1 FDA decision since 2001. No recall names this code.
A central venous stent is a prescription device for maintaining the luminal diameter of the central veins.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QKJ 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 · QKJ
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QKJ
Too few QKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QKJ
No recall names QKJ since 2007.
Adverse event reports per year · QKJ
1in 2022
MAUDE reports naming product code QKJ, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | — | 0 | 0 |
| 2012 | 9 | — | 0 | 0 |
| 2013 | 12 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 4 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in QKJ? 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