Stereo Optical Co., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stereo Optical Co., Inc.” (first 1984, latest 1993), across 2 product codes 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKO | Refractometer, Ophthalmic | 3 | 3 |
| HOX | Chart, Visual Acuity | 2 | 2 |
Review panels
- Ophthalmic (5)
Most recent Stereo Optical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924741 | OPTEC 3000 | HKO | 1993-04-06 | 196 |
| K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | HKO | 1991-01-18 | 86 |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | HOX | 1988-03-17 | 86 |
| K863509 | OPTEC 1000 DMV | HOX | 1986-11-10 | 62 |
| K843042 | VISION TESTER | HKO | 1984-10-05 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Stereo Optical Co., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Stereo Optical Co., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Stereo Optical Co., Inc.” (first 1984, latest 1993), across 2 product codes 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 Stereo Optical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stereo Optical Co., Inc. is 86 days.
Which FDA product codes appear under Stereo Optical Co., Inc.?
The most frequent FDA product codes under this applicant name are HKO (Refractometer, Ophthalmic, 3); HOX (Chart, Visual Acuity, 2).
Next steps
- See all 5 Stereo Optical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HKO, Stereo Optical Co., Inc.'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.