FDA product code · Neurology
Stimulator, Autonomic Nerve, Implanted For Epilepsy
1 FDA decision since 1997. 29 recalls name this code, 1 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LYJ 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 · LYJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYJ
Too few LYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LYJ
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LYJ
1,426in 2025
MAUDE reports naming product code LYJ, 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 | 21 | — | 4 | 1,889 |
| 2008 | 9 | — | 2 | 2,758 |
| 2009 | 3 | — | 2 | 2,688 |
| 2010 | 10 | — | 1 | 2,749 |
| 2011 | 24 | — | 3 | 3,042 |
| 2012 | 0 | — | 0 | 3,364 |
| 2013 | 0 | — | 0 | 3,809 |
| 2014 | 0 | — | 1 | 3,365 |
| 2015 | 2 | — | 3 | 3,265 |
| 2016 | 14 | — | 0 | 2,851 |
| 2017 | 9 | — | 1 | 2,074 |
| 2018 | 3 | — | 4 | 2,316 |
| 2019 | 7 | — | 1 (1) | 2,432 |
| 2020 | 6 | — | 2 | 1,688 |
| 2021 | 1 | — | 1 | 1,764 |
| 2022 | 3 | — | 0 | 1,584 |
| 2023 | 5 | — | 0 | 1,764 |
| 2024 | 3 | — | 0 | 1,524 |
| 2025 | 6 | — | 2 | 1,426 |
| 2026 | 3 | — | 0 | — |
Planning a device in LYJ? 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