Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Topcon Medical Systems, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
244 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182376 | Harmony | Topcon Medical Systems, Inc. | 2018-09-28 | 28 | 0 |
| K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015-10-01 | 78 | 0 |
| K132438 | IMAGENET 5 PC SOFTWARE SYSTEM | Topcon Medical Systems, Inc. | 2013-10-17 | 73 | 0 |
| K132667 | SYNERGY ODM | Topcon Medical Systems, Inc. | 2013-10-09 | 43 | 0 |
| K123101 | TRC-50DX RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-06-05 | 244 | 0 |
| K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-02-06 | 89 | 0 |
| K110489 | SLIT LAMP SL-2G | Topcon Medical Systems, Inc. | 2011-05-23 | 90 | 0 |
| K093313 | SYNERGY | Topcon Medical Systems, Inc. | 2009-12-02 | 41 | 0 |
| K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Medical Systems, Inc. | 2009-03-13 | 123 | 0 |
| K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR M | Topcon Medical Systems, Inc. | 2009-01-13 | 449 | 0 |
| K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Topcon Medical Systems, Inc. | 2003-12-19 | 189 | 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