Urotronic, Inc.: FDA clearances and approvals
Urotronic, Inc. has 2 FDA 510(k) clearances (first 2020, latest 2025), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time: 156 days. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 255 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 57 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Urotronic, Inc.'s cleared 510(k)s took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| KOE | Dilator, Urethral | 1 | 1 |
| QRH | Catheter, Balloon, Urethral, Drug-Coated | 1 | 0 |
| QXB | Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia | 1 | 0 |
Review panels
Most recent Urotronic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | EZN | 2025-05-22 | 57 |
| K191061 | Optilume Basic Urological Balloon Dilation Catheter | KOE | 2020-01-02 | 255 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220029 | PMA | Optilume BPH Catheter System | 2023-06-30 |
| P210020 | PMA | Optilume Urethral Drug Coated Balloon | 2021-12-03 |
Recalls
openFDA lists no recalls under a recalling firm named Urotronic, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Urotronic, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07020520: EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures (Recruiting, started 2025-10-01)
- NCT06312722: Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study (Recruiting, started 2024-02-07)
- NCT04131907: Optilume™ BPH Catheter System in Men With Symptomatic BPH (Active not recruiting, started 2020-02-05)
- NCT03499964: ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (Active not recruiting, started 2018-06-22)
- NCT03423979: Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter (Completed, started 2017-12-19)
Frequently asked questions
How many FDA 510(k) clearances does Urotronic, Inc. have?
Urotronic, Inc. has 2 FDA 510(k) clearances (first 2020, latest 2025), plus 2 PMA decisions, across 4 product codes in 1 review panel.
How long does FDA take to clear Urotronic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Urotronic, Inc.'s cleared 510(k)s is 156 days.
What devices does Urotronic, Inc. make?
Its most frequent FDA product codes are EZN (Dilator, Catheter, Ureteral, 1); KOE (Dilator, Urethral, 1); QRH (Catheter, Balloon, Urethral, Drug-Coated, 1).
Has Urotronic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Urotronic, Inc. Related entities may recall under other names.
Next steps
- See all 2 Urotronic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZN, Urotronic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.