FDA product code · Cardiovascular
Implantable Pulse Generator
1 FDA decision since 2019. No recall names this code.
Deliver Cardiac Contractility Modulation signals during the absolute refractory period
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QFV 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 · QFV
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFV
Too few QFV 510(k)s in any year since 2007 to give a median.
Recalls per year · QFV
No recall names QFV since 2007.
Adverse event reports per year · QFV
31in 2025
MAUDE reports naming product code QFV, 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 | 4 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 1 |
| 2021 | 4 | — | 0 | 0 |
| 2022 | 5 | — | 0 | 1 |
| 2023 | 9 | — | 0 | 24 |
| 2024 | 10 | — | 0 | 45 |
| 2025 | 5 | — | 0 | 31 |
| 2026 | 4 | — | 0 | — |
Planning a device in QFV? 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