Paragon Optical Co.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Paragon Optical Co.” (first 1981, latest 1981), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 238 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | 1 | 1 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | 1 | 0 |
Review panels
- Ophthalmic (2)
Most recent Paragon Optical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811010 | CONTACT LENS MATERL | HPX | 1981-12-09 | 238 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850038 | PMA | PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN | 1986-12-31 |
Recalls
openFDA lists no recalls under a recalling firm named Paragon Optical Co..
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.
- Paragon 28, Inc. (60 510(k)s)
- Paragon Vision Sciences (16 510(k)s)
- Paragon Trade Brands, Inc. (14 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Implant Mfg., LLC (5 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon Optical Co.?
FDA lists 1 510(k) clearance under the applicant name “Paragon Optical Co.” (first 1981, latest 1981), plus 1 PMA decision, 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 Paragon Optical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Optical Co. is 238 days.
Which FDA product codes appear under Paragon Optical Co.?
The most frequent FDA product codes under this applicant name are HPX (Lens, Contact (Polymethylmethacrylate), 1); MWL (Lens, Contact (Rigid Gas Permeable), Extended Wear, 1).
Next steps
- See all 1 Paragon Optical Co. clearances with predicates and recalls
- Run predicate analysis for product code HPX, Paragon Optical Co.'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.