FDA product code · Cardiovascular
Permanent Defibrillator Electrodes
2 FDA decisions since 1993. 4 recalls name this code, 0 of them Class I.
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NVY 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 · NVY
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVY
Too few NVY 510(k)s in any year since 2007 to give a median.
Recalls per year · NVY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVY
11,513in 2025
MAUDE reports naming product code NVY, 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 | 12 | — | 0 | 48 |
| 2008 | 27 | — | 0 | 63 |
| 2009 | 30 | — | 0 | 103 |
| 2010 | 82 | — | 0 | 1,796 |
| 2011 | 89 | — | 0 | 6,003 |
| 2012 | 92 | — | 0 | 8,520 |
| 2013 | 96 | — | 0 | 7,224 |
| 2014 | 86 | — | 0 | 9,530 |
| 2015 | 52 | — | 0 | 8,840 |
| 2016 | 39 | — | 0 | 8,567 |
| 2017 | 14 | — | 0 | 8,452 |
| 2018 | 20 | — | 0 | 8,322 |
| 2019 | 15 | — | 0 | 8,324 |
| 2020 | 13 | — | 0 | 8,020 |
| 2021 | 12 | — | 1 | 8,059 |
| 2022 | 10 | — | 2 | 7,636 |
| 2023 | 12 | — | 0 | 10,442 |
| 2024 | 12 | — | 0 | 9,362 |
| 2025 | 9 | — | 0 | 11,513 |
| 2026 | 10 | — | 1 | — |
Planning a device in NVY? 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