FDA product code · Neurology
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
1 FDA decision since 2020. No recall names this code.
Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QLK 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 · QLK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QLK
Too few QLK 510(k)s in any year since 2007 to give a median.
Recalls per year · QLK
No recall names QLK since 2007.
Adverse event reports per year · QLK
148in 2025
MAUDE reports naming product code QLK, 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 4 | — | 0 | 58 |
| 2024 | 2 | — | 0 | 103 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
Planning a device in QLK? 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