PMA · Approved
ApprovedOptilume Urethral Drug Coated Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urotronic, Inc. · QRH Catheter, Balloon, Urethral, Drug-Coated
Approved on May 17, 2022 through premarket approval, which rests on the device’s own clinical evidence after an 82-day review.
- Decided
- May 17, 2022
- Review
- 82 days
- Class
- Class III
- Product code
- QRH
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QRH devicesQRH Catheter, Balloon, Urethral, Drug-Coated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P210020/S004 · printed Nov 6, 2026
Cite this page
510(k) Report. “P210020/S004: Optilume Urethral Drug Coated Balloon.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P210020/S004
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026