Oculus Optikgerate GmbH: FDA clearances and approvals
Oculus Optikgerate GmbH has 6 FDA 510(k) clearances (first 2003, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 198 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 388 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 159 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 120 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Oculus Optikgerate GmbH's cleared 510(k)s took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 274 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | 5 | 5 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Oculus Optikgerate GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201724 | Pentacam AXL Wave | MXK | 2020-10-21 | 120 |
| K152311 | Pentacam AXL | MXK | 2016-01-20 | 159 |
| K113066 | CORVIS ST | HKX | 2012-11-08 | 388 |
| K073508 | PARKONE | MXK | 2008-09-11 | 273 |
| K041841 | PACHYCAM | MXK | 2005-01-28 | 204 |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | MXK | 2003-09-16 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Oculus Optikgerate GmbH.
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.
Frequently asked questions
How many FDA 510(k) clearances does Oculus Optikgerate GmbH have?
Oculus Optikgerate GmbH has 6 FDA 510(k) clearances (first 2003, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear Oculus Optikgerate GmbH's 510(k)s?
The median time from FDA receipt to decision across Oculus Optikgerate GmbH's cleared 510(k)s is 198 days.
What devices does Oculus Optikgerate GmbH make?
Its most frequent FDA product codes are MXK (Device, Analysis, Anterior Segment, 5); HKX (Tonometer, Ac-Powered, 1).
Has Oculus Optikgerate GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Oculus Optikgerate GmbH. Related entities may recall under other names.
Next steps
- See all 6 Oculus Optikgerate GmbH clearances with predicates and recalls
- Run predicate analysis for product code MXK, Oculus Optikgerate GmbH'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.