Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Urogen Pharma, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
231 daysmedian FDA review time
264 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 | 226 | 0 |
| K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | 2020-12-09 | 27 | 0 |
| K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2019-12-02 | 231 | 0 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 | 264 | 0 |
| K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2018-10-17 | 251 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda