FDA product code · Cardiovascular
Ablation Catheter, Renal Denervation
2 FDA decisions since 2023. No recall names this code.
For denervating the renal nerves to lower blood pressure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QYI 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 · QYI
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYI
Too few QYI 510(k)s in any year since 2007 to give a median.
Recalls per year · QYI
No recall names QYI since 2007.
Adverse event reports per year · QYI
14in 2025
MAUDE reports naming product code QYI, 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | — | 0 | 0 |
| 2024 | 13 | — | 0 | 17 |
| 2025 | 7 | — | 0 | 14 |
| 2026 | 7 | — | 0 | — |
Planning a device in QYI? 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