Australian Optical Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Australian Optical Co., Inc.” (first 1991, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | 5 | 5 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 3 | 3 |
Review panels
- Ophthalmic (8)
Most recent Australian Optical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943641 | SPECTACLE FRAME | HQZ | 1994-09-14 | 49 |
| K943640 | SUNGLASS CLIP | HQY | 1994-09-14 | 49 |
| K943562 | SUNGLASSES | HQY | 1994-09-14 | 54 |
| K943561 | SPECTACLE FRAME | HQZ | 1994-09-14 | 54 |
| K935678 | SUNGLASS FRAME | HQY | 1994-02-16 | 82 |
| K930331 | SPECTACLE FRAME | HQZ | 1993-12-08 | 320 |
| K911332 | SPECTACLE FRAME | HQZ | 1991-05-06 | 41 |
| K910179 | OPTICAL FRAME | HQZ | 1991-04-10 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Australian 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.
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.
- Australian Biomedical Corporation , Ltd. (5 510(k)s)
- Australian Surgical Design & Manufacture (1 510(k)s)
- Australian Surgical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Australian Optical Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Australian Optical Co., Inc.” (first 1991, latest 1994), 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 Australian Optical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Australian Optical Co., Inc. is 54 days.
Which FDA product codes appear under Australian Optical Co., Inc.?
The most frequent FDA product codes under this applicant name are HQZ (Frame, Spectacle, 5); HQY (Sunglasses (Non-Prescription Including Photosensitive), 3).
Next steps
- See all 8 Australian Optical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQZ, Australian 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.