Optomed OY: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Optomed OY” (first 2009, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 156 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 162 |
| 2018 | 1 | 52 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Optomed OY took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Optomed OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | HKI | 2018-04-05 | 52 |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | HKI | 2017-04-11 | 162 |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | HKI | 2013-12-18 | 156 |
| K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | HKI | 2011-05-16 | 38 |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | HKI | 2009-10-01 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Optomed OY.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Optomed Corp. (2 510(k)s)
- Optomed Oyj (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Optomed OY?
FDA lists 5 510(k) clearances under the applicant name “Optomed OY” (first 2009, latest 2018), 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 Optomed OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optomed OY is 86 days.
Which FDA product codes appear under Optomed OY?
The most frequent FDA product codes under this applicant name are HKI (Camera, Ophthalmic, Ac-Powered, 5).
Next steps
- See all 5 Optomed OY clearances with predicates and recalls
- Run predicate analysis for product code HKI, Optomed OY'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.