Topcon Corporation: FDA clearances and approvals
Topcon Corporation has 23 FDA 510(k) clearances (first 2004, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time: 136 days. Since 2017 its median was 124 days, against 156 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 9 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 94 |
| 2014 | 3 | 156 |
| 2015 | 1 | 274 |
| 2016 | 2 | 100 |
| 2017 | 2 | 110 |
| 2018 | 1 | 112 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 136 |
| 2023 | 1 | 185 |
| 2024 | 3 | 156 |
| 2025 | 1 | 46 |
| 2026 | 1 | 51 |
Review time against the same product codes
Since 2017, Topcon Corporation's cleared 510(k)s took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | 8 | 8 |
| HKI | Camera, Ophthalmic, Ac-Powered | 7 | 7 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 3 | 3 |
| NFJ | System, Image Management, Ophthalmic | 3 | 3 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| NQE | Microscope, Specular | 1 | 1 |
Review panels
- Ophthalmic (23)
Most recent Topcon Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262637 | SLIT LAMP SL-D4 (Type: LED) | HJO | 2026-09-18 | 51 |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | HKX | 2025-11-07 | 46 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | OBO | 2024-07-17 | 89 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | OBO | 2024-04-10 | 156 |
| K232828 | IMAGEnet6 Ophthalmic Data System | NFJ | 2024-03-01 | 170 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | OBO | 2023-10-30 | 185 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | HKI | 2022-08-29 | 136 |
| K173119 | DRI OCT Triton | OBO | 2018-01-19 | 112 |
| K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 | 175 |
| K170164 | 3D OCT-1 Maestro | OBO | 2017-03-03 | 44 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Topcon 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
Topcon Corporation is the industry lead sponsor of 9 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06733428: Agreement and Precision Study (Completed, started 2025-01-09)
- NCT06250868: TRK-3 Performance of Pachymetry (Completed, started 2024-02-20)
- NCT06247072: TRK-3 Conformance to Standards for Tonometers (Completed, started 2024-02-02)
- NCT05286502: NW500 Non-Mydriatic Retinal Camera Clinical Performance Study (Completed, started 2022-03-01)
- NCT05283343: Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision (Completed, started 2021-11-27)
Frequently asked questions
How many FDA 510(k) clearances does Topcon Corporation have?
Topcon Corporation has 23 FDA 510(k) clearances (first 2004, latest 2026), across 6 product codes in 1 review panel.
How long does FDA take to clear Topcon Corporation's 510(k)s?
The median time from FDA receipt to decision across Topcon Corporation's cleared 510(k)s is 136 days. Since 2017: 124 days, versus 156 days for all cleared 510(k)s in the same product codes.
What devices does Topcon Corporation make?
Its most frequent FDA product codes are OBO (Tomography, Optical Coherence, 8); HKI (Camera, Ophthalmic, Ac-Powered, 7); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 3).
Has Topcon Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Topcon Corporation. Related entities may recall under other names.
Next steps
- See all 23 Topcon Corporation clearances with predicates and recalls
- Run predicate analysis for product code OBO, Topcon 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.