Olympic Ophthalmics: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Olympic Ophthalmics” (first 2022, latest 2022), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 120 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 |
|---|---|---|
| 2022 | 1 | 120 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Olympic Ophthalmics 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 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QKV | Electromechanical Tear Stimulator | 2 | 1 |
Review panels
- Ophthalmic (2)
Most recent Olympic Ophthalmics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213623 | iTEAR100 Neurostimulator | QKV | 2022-03-16 | 120 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190026 | De Novo | Electromechanical Tear Stimulator | 2020-05-01 |
Recalls
openFDA lists no recalls under a recalling firm named Olympic Ophthalmics.
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.
- Olympic Medical Corp. (37 510(k)s)
- Olympic Controls Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olympic Ophthalmics?
FDA lists 1 510(k) clearance under the applicant name “Olympic Ophthalmics” (first 2022, latest 2022), 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 Olympic Ophthalmics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olympic Ophthalmics is 120 days.
Which FDA product codes appear under Olympic Ophthalmics?
The most frequent FDA product codes under this applicant name are QKV (Electromechanical Tear Stimulator, 2).
Next steps
- See all 1 Olympic Ophthalmics clearances with predicates and recalls
- Run predicate analysis for product code QKV, Olympic Ophthalmics'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.