Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viveve, 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) |
|---|---|---|---|---|---|
| K213814 | Viveve 2.0 System | Viveve, Inc. | 2022-02-02 | 57 | 0 |
| K180584 | Viveve RF System, Secure | Viveve, Inc. | 2018-04-06 | 32 | 0 |
| K162547 | Viveve System | Viveve, Inc. | 2016-10-06 | 24 | 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