FDA product code · Gastroenterology and urology
Catheter, Balloon, Urethral, Drug-Coated
1 FDA decision since 2021. No recall names this code.
Dilate urethral strictures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QRH 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 · QRH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRH
Too few QRH 510(k)s in any year since 2007 to give a median.
Recalls per year · QRH
No recall names QRH since 2007.
Adverse event reports per year · QRH
6in 2025
MAUDE reports naming product code QRH, 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 | 1 | — | 0 | 0 |
| 2022 | 6 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
Planning a device in QRH? 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