FDA product code · Cardiovascular
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
3 FDA decisions since 2007. No recall names this code.
Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OJX 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 · OJX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OJX
Too few OJX 510(k)s in any year since 2007 to give a median.
Recalls per year · OJX
No recall names OJX since 2007.
Adverse event reports per year · OJX
3,372in 2025
MAUDE reports naming product code OJX, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 9 | — | 0 | 66 |
| 2010 | 41 | — | 0 | 1,437 |
| 2011 | 63 | — | 0 | 3,030 |
| 2012 | 47 | — | 0 | 2,417 |
| 2013 | 41 | — | 0 | 2,482 |
| 2014 | 16 | — | 0 | 3,002 |
| 2015 | 11 | — | 0 | 3,724 |
| 2016 | 27 | — | 0 | 3,030 |
| 2017 | 19 | — | 0 | 3,293 |
| 2018 | 24 | — | 0 | 3,978 |
| 2019 | 21 | — | 0 | 3,926 |
| 2020 | 19 | — | 0 | 2,776 |
| 2021 | 19 | — | 0 | 2,869 |
| 2022 | 9 | — | 0 | 2,947 |
| 2023 | 11 | — | 0 | 4,468 |
| 2024 | 7 | — | 0 | 3,395 |
| 2025 | 5 | — | 0 | 3,372 |
| 2026 | 3 | — | 0 | — |
Planning a device in OJX? 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