Tomey Corporation USA: FDA clearances and approvals
Tomey Corporation USA has 9 FDA 510(k) clearances (first 1991, latest 1997), across 8 product codes in 2 review panels. Median 510(k) review time: 84 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HKO | Refractometer, Ophthalmic | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | 1 | 1 |
| HLZ | Electrode, Corneal | 1 | 1 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 1 | 1 |
Review panels
- Ophthalmic (8)
- Neurology (1)
Most recent Tomey Corporation USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971953 | CONFOSCAN | HJO | 1997-08-14 | 78 |
| K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | HKI | 1997-06-24 | 48 |
| K961805 | TOMEY DTL ELECTRODE | HLZ | 1997-05-09 | 364 |
| K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 | GWE | 1995-08-31 | 826 |
| K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 | HKO | 1995-03-01 | 84 |
| K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE | HJO | 1994-11-22 | 48 |
| K924760 | TOMEY PROTON TONOMETER | HKY | 1993-04-05 | 194 |
| K921815 | TOMEY PE-300 PORTABLE ERG | HLT | 1992-07-15 | 91 |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | LQJ | 1991-06-17 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Tomey Corporation USA.
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 Tomey Corporation USA have?
Tomey Corporation USA has 9 FDA 510(k) clearances (first 1991, latest 1997), across 8 product codes in 2 review panels.
How long does FDA take to clear Tomey Corporation USA's 510(k)s?
The median time from FDA receipt to decision across Tomey Corporation USA's cleared 510(k)s is 84 days.
What devices does Tomey Corporation USA make?
Its most frequent FDA product codes are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); GWE (Stimulator, Photic, Evoked Response, 1); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Has Tomey Corporation USA had device recalls?
openFDA lists no recalls under a recalling firm name matching Tomey Corporation USA. Related entities may recall under other names.
Next steps
- See all 9 Tomey Corporation USA clearances with predicates and recalls
- Run predicate analysis for product code HJO, Tomey Corporation USA'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.