Eaton Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Eaton Medical Corp.” (first 1984, latest 1993), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 167 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 |
|---|---|---|---|
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 2 | 2 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 1 | 1 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 1 | 1 |
| LRX | Case, Contact Lens | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Eaton Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931718 | SPIRIT SHIELD | HQY | 1993-09-20 | 167 |
| K921882 | THE CLEANER ACCESSORY | LYL | 1992-08-25 | 126 |
| K904824 | EASY EYES TM CONTACT LENS CLEANING MACHINE | LYL | 1991-07-05 | 253 |
| K871741 | EASY EYES TM LENS CARRYING CASE | LRX | 1987-07-22 | 78 |
| K841881 | EASY EYES TM LENS CARRYING CASE | HPX | 1984-12-03 | 210 |
Recalls
openFDA lists no recalls under a recalling firm named Eaton Medical Corp..
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.
- Eaton Medical Group (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eaton Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Eaton Medical Corp.” (first 1984, latest 1993), across 4 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 Eaton Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eaton Medical Corp. is 167 days.
Which FDA product codes appear under Eaton Medical Corp.?
The most frequent FDA product codes under this applicant name are LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses, 2); HPX (Lens, Contact (Polymethylmethacrylate), 1); HQY (Sunglasses (Non-Prescription Including Photosensitive), 1).
Next steps
- See all 5 Eaton Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYL, Eaton Medical Corp.'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.