The Orvis Co., Inc.: FDA clearances and approvals
The Orvis Co., Inc. has 9 FDA 510(k) clearances (first 1994, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time: 40 days.
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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 9 | 9 |
Review panels
- Ophthalmic (9)
Most recent The Orvis Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950609 | ORVIS KEY WEST SUNGLASSES | HQY | 1995-03-02 | 20 |
| K943161 | ORVIS DRIVING GLASSES | HQY | 1994-08-04 | 34 |
| K943131 | ORVIS POLARIZED BI-FOCALS | HQY | 1994-08-02 | 34 |
| K942951 | ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS | HQY | 1994-08-02 | 40 |
| K942952 | ORVIS WORLD FINEST POLARIZED CLIP ONS | HQY | 1994-07-25 | 32 |
| K941910 | SUNGLASSES | HQY | 1994-07-08 | 80 |
| K941751 | SUNGLASSES | HQY | 1994-06-03 | 56 |
| K940354 | ORVIS MARQUESAS FISHING GLASSES | HQY | 1994-03-24 | 58 |
| K940292 | ORVIS RIVER GUIDE GLASSES | HQY | 1994-03-24 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named The Orvis Co., Inc..
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 The Orvis Co., Inc. have?
The Orvis Co., Inc. has 9 FDA 510(k) clearances (first 1994, latest 1995), across 1 product code in 1 review panel.
How long does FDA take to clear The Orvis Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across The Orvis Co., Inc.'s cleared 510(k)s is 40 days.
What devices does The Orvis Co., Inc. make?
Its most frequent FDA product codes are HQY (Sunglasses (Non-Prescription Including Photosensitive), 9).
Has The Orvis Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Orvis Co., Inc. Related entities may recall under other names.
Next steps
- See all 9 The Orvis Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQY, The Orvis Co., Inc.'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.