Tomey Corporation: FDA clearances and approvals
Tomey Corporation has 6 FDA 510(k) clearances (first 2002, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time: 220 days. Since 2017 its median was 176 days, against 147 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 260 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 209 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 142 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Tomey Corporation's cleared 510(k)s took a median 176 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | 2 | 2 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| MXK | Device, Analysis, Anterior Segment | 1 | 1 |
| NQE | Microscope, Specular | 1 | 1 |
Review panels
- Ophthalmic (5)
- Radiology (1)
Most recent Tomey Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | MXK | 2025-12-18 | 142 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | OBO | 2025-07-18 | 143 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | OBO | 2022-04-27 | 209 |
| K171313 | EM-4000 Specular Microscope | NQE | 2018-01-19 | 260 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | HKX | 2008-11-18 | 383 |
| K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER | IYO | 2002-04-08 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named Tomey Corporation.
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.
Device clinical trials
Tomey Corporation is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04486976: Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software (Completed, started 2020-06-27)
- NCT02977793: Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL (Completed, started 2016-10)
- NCT02293122: To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL) (Completed, started 2014-11)
- NCT02077790: To Investigate the Precision and Agreement of SS-1000 and Pentacam in a Repeatability and Reproducibility Trial (Completed, started 2013-09)
Frequently asked questions
How many FDA 510(k) clearances does Tomey Corporation have?
Tomey Corporation has 6 FDA 510(k) clearances (first 2002, latest 2025), across 5 product codes in 2 review panels.
How long does FDA take to clear Tomey Corporation's 510(k)s?
The median time from FDA receipt to decision across Tomey Corporation's cleared 510(k)s is 220 days. Since 2017: 176 days, versus 147 days for all cleared 510(k)s in the same product codes.
What devices does Tomey Corporation make?
Its most frequent FDA product codes are OBO (Tomography, Optical Coherence, 2); HKX (Tonometer, Ac-Powered, 1); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Has Tomey Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Tomey Corporation. Related entities may recall under other names.
Next steps
- See all 6 Tomey Corporation clearances with predicates and recalls
- Run predicate analysis for product code OBO, Tomey Corporation'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.