FDA product code · Gastroenterology and urology
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
4 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 157 days (half between 157 and 157). No recall names this code. The most-cited predicate is DEN190020, named by 2 later devices.
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QKA 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 · QKA
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QKA
Too few QKA 510(k)s in any year since 2007 to give a median.
Recalls per year · QKA
No recall names QKA since 2007.
Adverse event reports per year · QKA
5in 2025
MAUDE reports naming product code QKA, 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 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
Planning a device in QKA? 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