FDA product code · Cardiovascular
Shockwave Intravascular Lithotripsy System
1 FDA decision since 2021. No recall names this code.
Dilatation of coronary arteries prior to stenting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QMG 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 · QMG
6so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QMG
Too few QMG 510(k)s in any year since 2007 to give a median.
Recalls per year · QMG
No recall names QMG since 2007.
Adverse event reports per year · QMG
127in 2025
MAUDE reports naming product code QMG, 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 | 4 | — | 0 | 21 |
| 2022 | 4 | — | 0 | 57 |
| 2023 | 5 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 113 |
| 2025 | 4 | — | 0 | 127 |
| 2026 | 6 | — | 0 | — |
Planning a device in QMG? 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