Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oventus Manufacturing Pty, Ltd. — 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) |
|---|---|---|---|---|---|
| K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019-08-29 | 204 | 0 |
| K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017-07-11 | 68 | 0 |
| K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016-09-23 | 80 | 0 |
| K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016-03-17 | 45 | 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