FDA product code · Gastroenterology and urology
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
2 FDA decisions since 2022. No recall names this code.
Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QPT 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 · QPT
14so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPT
Too few QPT 510(k)s in any year since 2007 to give a median.
Recalls per year · QPT
No recall names QPT since 2007.
Adverse event reports per year · QPT
6in 2025
MAUDE reports naming product code QPT, 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 4 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 7 | — | 0 | 6 |
| 2026 | 14 | — | 0 | — |
Planning a device in QPT? 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