PMA · Approved
ApprovedVNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LivaNova USA, Inc. · LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Approved on Nov 25, 2025 through premarket approval, which rests on the device’s own clinical evidence after an 84-day review.
- Decided
- Nov 25, 2025
- Review
- 84 days
- Class
- Class III
- Product code
- LYJ
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LYJ devicesLYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P970003/S251 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970003/S251: VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970003/S251
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026