PMA · Approved
ApprovedShockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shockwave Medical, Inc. · QMG Shockwave Intravascular Lithotripsy System
Approved on Mar 5, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 30-day review.
- Decided
- Mar 5, 2026
- Review
- 30 days
- Class
- Class III
- Product code
- QMG
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QMG devicesQMG Shockwave Intravascular Lithotripsy System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P200039/S020 · printed Nov 4, 2026
Cite this page
510(k) Report. “P200039/S020: Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P200039/S020
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026