FDA product code · Cardiovascular
Coronary Mechanical Thrombectomy With Aspiration
3 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 55 days (half between 55 and 55). No recall names this code. The most-cited predicate is K171493, named by 3 later devices.
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QEX 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 · QEX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEX
Too few QEX 510(k)s in any year since 2007 to give a median.
Recalls per year · QEX
No recall names QEX since 2007.
Adverse event reports per year · QEX
23in 2025
MAUDE reports naming product code QEX, 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 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 1 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
Planning a device in QEX? 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) ReportRelated product codes
Other codes under 21 CFR 870.5150.