Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stereo Optical Co., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
196 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924741 | OPTEC 3000 | Stereo Optical Co., Inc. | 1993-04-06 | 196 | 0 |
| K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | Stereo Optical Co., Inc. | 1991-01-18 | 86 | 0 |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Stereo Optical Co., Inc. | 1988-03-17 | 86 | 0 |
| K863509 | OPTEC 1000 DMV | Stereo Optical Co., Inc. | 1986-11-10 | 62 | 0 |
| K843042 | VISION TESTER | Stereo Optical Co., Inc. | 1984-10-05 | 64 | 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