Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Topcon Corporation — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
185 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | 2025-11-07 | 46 | 0 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); I | Topcon Corporation | 2024-07-17 | 89 | 0 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024-04-10 | 156 | 0 |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-03-01 | 170 | 1 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023-10-30 | 185 | 0 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | 2022-08-29 | 136 | 0 |
| K173119 | DRI OCT Triton | Topcon Corporation | 2018-01-19 | 112 | 0 |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017-11-01 | 175 | 1 |
| K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017-03-03 | 44 | 0 |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016-12-09 | 144 | 0 |
| K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016-07-28 | 57 | 0 |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015-05-29 | 274 | 0 |
| K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | Topcon Corporation | 2014-09-17 | 105 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda