Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnimedical — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
62 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K837378 | OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM | Omnimedical | 1983-05-18 | 62 | 0 |
| K820180 | CALCULI FILTER CUP | Omnimedical | 1982-02-05 | 14 | 0 |
| K812393 | 4001 CT SCANNER | Omnimedical | 1981-10-13 | 54 | 0 |
| K812400 | OMNIMEDICAL QUAD I | Omnimedical | 1981-10-02 | 43 | 0 |
| K802206 | OMNI SCANNER CT 6000 | Omnimedical | 1980-10-23 | 42 | 0 |
| K790673 | OMNIMEDICAL AUTOMATIC 1001 | Omnimedical | 1979-05-04 | 25 | 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