Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optimed, 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) |
|---|---|---|---|---|---|
| K903462 | OPTIMED GLAUCOMA PRESSURE REGULATOR | Optimed, Inc. | 1990-10-16 | 76 | 0 |
| K890687 | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER | Optimed, Inc. | 1989-09-05 | 208 | 0 |
| K884867 | OPTIFIELD I AND II AUTOMATED PERIMETERS | Optimed, Inc. | 1989-03-09 | 108 | 0 |
| K883458 | OPTIMED ADVANTAGE | Optimed, Inc. | 1988-11-07 | 87 | 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