Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renovia, 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) |
|---|---|---|---|---|---|
| K213913 | leva Pelvic Health System | Renovia, Inc. | 2022-06-30 | 197 | 0 |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021-09-08 | 30 | 0 |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019-11-22 | 92 | 0 |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018-04-04 | 23 | 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