FDA product code · Neurology
Implanted Brain Stimulator For Epilepsy
1 FDA decision since 2013. No recall names this code.
For the treatment of epilepsy.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PFN 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 · PFN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PFN
Too few PFN 510(k)s in any year since 2007 to give a median.
Recalls per year · PFN
No recall names PFN since 2007.
Adverse event reports per year · PFN
89in 2025
MAUDE reports naming product code PFN, 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 | 3 | — | 0 | 0 |
| 2014 | 22 | — | 0 | 15 |
| 2015 | 13 | — | 0 | 36 |
| 2016 | 8 | — | 0 | 28 |
| 2017 | 4 | — | 0 | 63 |
| 2018 | 10 | — | 0 | 54 |
| 2019 | 12 | — | 0 | 59 |
| 2020 | 8 | — | 0 | 66 |
| 2021 | 3 | — | 0 | 57 |
| 2022 | 3 | — | 0 | 49 |
| 2023 | 4 | — | 0 | 67 |
| 2024 | 3 | — | 0 | 86 |
| 2025 | 2 | — | 0 | 89 |
| 2026 | 4 | — | 0 | — |
Planning a device in PFN? 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