Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uro-1, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220611 | SUREcore Plus Biopsy Instrument | Uro-1, Inc. | 2022-12-02 | 274 | 0 |
| K201650 | VMCore Biopsy Needle | Uro-1, Inc. | 2021-01-15 | 211 | 0 |
| K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018-05-03 | 98 | 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