Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Urotronic, Inc. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025-05-22 | 57 | 0 |
| K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020-01-02 | 255 | 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