Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vivorte, 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) |
|---|---|---|---|---|---|
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | 2015-01-14 | 30 | 1 |
| K143549 | Vivorte Trabexus | Vivorte, Inc. | 2015-01-14 | 30 | 0 |
| K130703 | VIVORTE BVF | Vivorte, Inc. | 2013-09-12 | 181 | 1 |
| K131133 | VIVORTE BVF LITE | Vivorte, Inc. | 2013-08-12 | 111 | 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