Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omega Universal Technologies, Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924228 | OMEGASCOPE | Omega Universal Technologies, Ltd. | 1993-02-26 | 189 | 0 |
| K920439 | OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE | Omega Universal Technologies, Ltd. | 1992-09-04 | 214 | 0 |
| K911090 | OMEGA ANGIOSCOPES (OMEGASCOPES) | Omega Universal Technologies, Ltd. | 1991-07-31 | 142 | 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