Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eye Garter Company, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
186 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900941 | OMNIPATCH | Eye Garter Company, Inc. | 1990-05-21 | 82 | 0 |
| K896172 | STRAPPED EYE SHIELD | Eye Garter Company, Inc. | 1989-11-03 | 9 | 0 |
| K896171 | EYE PATCH | Eye Garter Company, Inc. | 1989-11-03 | 9 | 0 |
| K880489 | CLEAR EYE GARTER SHIELD | Eye Garter Company, Inc. | 1988-08-08 | 186 | 0 |
| K880490 | BLUE PLASTIC EYE SHIELD | Eye Garter Company, Inc. | 1988-05-03 | 89 | 0 |
| K880675 | EASY SHIELD ADHESIVE BANDAGE | Eye Garter Company, Inc. | 1988-04-01 | 42 | 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