Oculogica, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oculogica, Inc.” (first 2019, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 152 days. Since 2017 the median was 152 days, against 160 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 1 | 66 |
| 2021 | 1 | 152 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 259 |
| 2026 | 1 | 169 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oculogica, Inc. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | 6 | 5 |
Review panels
- Neurology (6)
Most recent Oculogica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254086 | EyeBOX SNAP | QEA | 2026-06-05 | 169 |
| K242116 | EyeBOX EBX-4.1 | QEA | 2025-04-04 | 259 |
| K212310 | EyeBOX (Model EBX-4) | QEA | 2021-12-22 | 152 |
| K201841 | EyeBOX | QEA | 2020-09-06 | 66 |
| K191183 | EyeBOX | QEA | 2019-07-31 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170091 | De Novo | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | 2018-12-28 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-04-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Oculogica, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05527041: A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings (Enrolling by invitation, started 2023-07-01)
- NCT05047003: Oculogica Portable EyeBOX Study (Completed, started 2020-12-19)
- NCT03966404: EyeBOX Concussion Study and Registry (Completed, started 2019-08-05)
- NCT03418753: Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure (Completed, started 2018-05-10)
- NCT02776462: Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients (Completed, started 2016-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oculogica, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Oculogica, Inc.” (first 2019, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oculogica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oculogica, Inc. is 152 days. Since 2017: 152 days, versus 160 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oculogica, Inc.?
The most frequent FDA product codes under this applicant name are QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid, 6).
Next steps
- See all 5 Oculogica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEA, Oculogica, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.