Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oculogica, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
371 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026-06-05 | 169 | 0 |
| K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025-04-04 | 259 | 0 |
| K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021-12-22 | 152 | 0 |
| K201841 | EyeBOX | Oculogica, Inc. | 2020-09-06 | 66 | 0 |
| K191183 | EyeBOX | Oculogica, Inc. | 2019-07-31 | 90 | 0 |
| DEN170091 | EyeBOX | Oculogica, Inc. | 2018-12-28 | 371 | 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