Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renovorx, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212324 | RenovoCath | Renovorx, Inc. | 2021-08-23 | 28 | 0 |
| K191606 | RenovoCath | Renovorx, Inc. | 2019-08-07 | 51 | 0 |
| K160067 | RenovoCath | Renovorx, Inc. | 2017-03-07 | 419 | 0 |
| K141175 | RENOVOCATH RC120 | Renovorx, Inc. | 2014-10-24 | 171 | 1 |
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