Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vesta, 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) |
|---|---|---|---|---|---|
| K834078 | SILICONE RUGGER DISPOSABLE YOKE-CPAP | Vesta, Inc. | 1983-12-27 | 29 | 0 |
| K810960 | NASOPHARYNGEAL AIRWAY | Vesta, Inc. | 1981-04-23 | 15 | 0 |
| K792719 | 3 WAY URETHRAL IRRIGATION CATHETER | Vesta, Inc. | 1980-01-16 | 19 | 0 |
| K792018 | SILICONE RUBBER-BI NASOPHARYNGEAL AIR | Vesta, Inc. | 1979-11-13 | 35 | 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