Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthosonics, 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) |
|---|---|---|---|---|---|
| K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010-02-19 | 70 | 0 |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | 2009-03-20 | 87 | 0 |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | 2005-07-21 | 87 | 0 |
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | 2002-06-06 | 28 | 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