Eye Garter Company, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Eye Garter Company, Inc.” (first 1988, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 6 | 6 |
Review panels
- Ophthalmic (6)
Most recent Eye Garter Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900941 | OMNIPATCH | HOY | 1990-05-21 | 82 |
| K896172 | STRAPPED EYE SHIELD | HOY | 1989-11-03 | 9 |
| K896171 | EYE PATCH | HOY | 1989-11-03 | 9 |
| K880489 | CLEAR EYE GARTER SHIELD | HOY | 1988-08-08 | 186 |
| K880490 | BLUE PLASTIC EYE SHIELD | HOY | 1988-05-03 | 89 |
| K880675 | EASY SHIELD ADHESIVE BANDAGE | HOY | 1988-04-01 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Eye Garter Company, 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 Eye Garter Company, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Eye Garter Company, Inc.” (first 1988, latest 1990), 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 Eye Garter Company, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eye Garter Company, Inc. is 62 days.
Which FDA product codes appear under Eye Garter Company, Inc.?
The most frequent FDA product codes under this applicant name are HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), 6).
Next steps
- See all 6 Eye Garter Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HOY, Eye Garter Company, 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.