Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Expanded Optics, Inc. — 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) |
|---|---|---|---|---|---|
| K922321 | OMNI ARTHROSCOPE | Expanded Optics, Inc. | 1993-08-03 | 442 | 0 |
| K922319 | OMNI LAPAROSCOPE | Expanded Optics, Inc. | 1993-04-23 | 340 | 0 |
| K922320 | OMNI CYSTOSCOPE | Expanded Optics, Inc. | 1993-01-13 | 240 | 0 |
| K894570 | UNIVERSAL LIGHT CABLE | Expanded Optics, Inc. | 1989-10-13 | 84 | 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