Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omikron Scientific, 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) |
|---|---|---|---|---|---|
| K904445 | OMIBAND | Omikron Scientific, Ltd. | 1991-03-06 | 159 | 0 |
| K874480 | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) | Omikron Scientific, Ltd. | 1988-02-22 | 112 | 0 |
| K844277 | OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR | Omikron Scientific, Ltd. | 1985-02-15 | 102 | 0 |
| K840748 | LITHIUM PACEMAKER 811-811L & 811XL | Omikron Scientific, Ltd. | 1984-08-03 | 162 | 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