Data / Medical devices / United States / Oculogica Inc.
Oculogica Inc.: FDA-registered device maker in New Richmond, WI, United States, 5 510(k) clearances
Oculogica Inc. is registered with the FDA (registration 3014535677) in New Richmond, WI, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated April 4, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014535677
- Address
- 1477 South Knowles Avenue Suite 110F, New Richmond, WI, United States, 54017
- Owner or operator
- Oculogica Inc. (10059744)
- Roles
- Specification developer
- First device listed
- February 19, 2019
- Registered through
- 2026
- Brand names listed
- EyeBOX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | QEA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2025 | K242116 | EyeBOX EBX-4.1 | QEA | Substantially Equivalent | Oculogica, Inc. | accessdata.fda.gov |
| December 22, 2021 | K212310 | EyeBOX (Model EBX-4) | QEA | Substantially Equivalent | Oculogica, Inc. | accessdata.fda.gov |
| September 6, 2020 | K201841 | EyeBOX | QEA | Substantially Equivalent | Oculogica, Inc. | accessdata.fda.gov |
| July 31, 2019 | K191183 | EyeBOX | QEA | Substantially Equivalent | Oculogica, Inc. | accessdata.fda.gov |
| December 28, 2018 | DEN170091 | EyeBOX | QEA | Unknown | Oculogica, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 16, 2019 | 82922 | Class II | Terminated | EyeBOX Model OCL 02 | A review of the user manual revealed that two precaution statements were missing. | accessdata.fda.gov |
Compare with other makers
Updated April 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.