FDA product code · Neurology
Dorsal Root Ganglion Stimulator For Pain Relief
1 FDA decision since 2016. No recall names this code.
Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PMP 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 · PMP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMP
Too few PMP 510(k)s in any year since 2007 to give a median.
Recalls per year · PMP
No recall names PMP since 2007.
Adverse event reports per year · PMP
1,956in 2025
MAUDE reports naming product code PMP, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | — | 0 | 286 |
| 2017 | 13 | — | 0 | 1,141 |
| 2018 | 8 | — | 0 | 2,136 |
| 2019 | 5 | — | 0 | 2,549 |
| 2020 | 8 | — | 0 | 2,323 |
| 2021 | 13 | — | 0 | 2,304 |
| 2022 | 3 | — | 0 | 1,958 |
| 2023 | 9 | — | 0 | 1,823 |
| 2024 | 13 | — | 0 | 2,074 |
| 2025 | 11 | — | 0 | 1,956 |
| 2026 | 6 | — | 0 | — |
Planning a device in PMP? 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