Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha Omega , 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) |
|---|---|---|---|---|---|
| K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE | Alpha Omega , Ltd. | 2007-12-03 | 166 | 0 |
| K051830 | NEURODRIVE SYSTEM | Alpha Omega , Ltd. | 2005-09-16 | 72 | 0 |
| K013396 | ALPHA DRIVE SYSTEM | Alpha Omega , Ltd. | 2002-08-07 | 296 | 0 |
| K993622 | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY | Alpha Omega , Ltd. | 2000-01-24 | 90 | 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