Optovue, Inc.: FDA clearances and approvals
Optovue, Inc. has 16 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time: 111 days. Since 2017 its median was 111 days, against 156 days for all cleared 510(k)s in the same product codes. openFDA lists 9 product recalls by a recalling firm named Optovue, Inc. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 68 |
| 2013 | 3 | 141 |
| 2014 | 1 | 89 |
| 2015 | 0 | — |
| 2016 | 1 | 111 |
| 2017 | 1 | 179 |
| 2018 | 1 | 86 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 111 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Optovue, Inc.'s cleared 510(k)s took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 7 | 7 |
| OBO | Tomography, Optical Coherence | 7 | 7 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 2 |
Review panels
- Ophthalmic (16)
Most recent Optovue, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222166 | SOLIX | OBO | 2022-11-09 | 111 |
| K180660 | Avanti | OBO | 2018-06-08 | 86 |
| K163475 | iVue | OBO | 2017-06-09 | 179 |
| K153080 | RTVue XR OCT Avanti with AngioVue Software | HLI | 2016-02-11 | 111 |
| K133892 | IVUE 500 | HLI | 2014-03-19 | 89 |
| K130656 | IFUSION | HKI | 2013-07-03 | 113 |
| K121739 | IVUE WITH NORMATIVE DATABASE | HLI | 2013-01-18 | 219 |
| K122572 | ICAM FUNDUS CAMERA | HKI | 2013-01-11 | 141 |
| K120238 | RTVUE XR OCT | HLI | 2012-04-03 | 68 |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | OBO | 2011-09-08 | 100 |
6 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2017-07-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Optovue, Inc. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04437082: Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography) (Completed, started 2021-01-15)
- NCT03887104: Data Collection of OCT and OCTA-based Ocular Measurements (Completed, started 2019-02-08)
- NCT03859310: Precision of OCT and OCTA-based Ocular Measurements (Completed, started 2019-01-29)
- NCT03852485: Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate (Completed, started 2019-01-29)
- NCT02911883: Evaluation of the Repeatability and Reproducibility of AngioVue (Completed, started 2016-08-29)
Frequently asked questions
How many FDA 510(k) clearances does Optovue, Inc. have?
Optovue, Inc. has 16 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 1 review panel.
How long does FDA take to clear Optovue, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Optovue, Inc.'s cleared 510(k)s is 111 days. Since 2017: 111 days, versus 156 days for all cleared 510(k)s in the same product codes.
What devices does Optovue, Inc. make?
Its most frequent FDA product codes are HLI (Ophthalmoscope, Ac-Powered, 7); OBO (Tomography, Optical Coherence, 7); HKI (Camera, Ophthalmic, Ac-Powered, 2).
Has Optovue, Inc. had device recalls?
openFDA lists 9 product recalls in 7 recall events by a recalling firm whose name matches Optovue, Inc; the most recent began 2017-07-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Optovue, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HLI, Optovue, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.