Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Topcon Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
270 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2014-10-23 | 156 | 0 |
| K133667 | SLIT LAMP SL-D701 | Topcon Corp. | 2014-08-26 | 270 | 0 |
| K130289 | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2013-05-10 | 94 | 0 |
| K100207 | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F | Topcon Corp. | 2010-02-12 | 18 | 0 |
| K092470 | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 | Topcon Corp. | 2009-09-02 | 21 | 0 |
| K090115 | RETINA CAMERA TRC-NW7SF MARK II | Topcon Corp. | 2009-06-30 | 160 | 0 |
| K082364 | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESS | Topcon Corp. | 2008-09-30 | 43 | 0 |
| K063388 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Corp. | 2007-06-22 | 226 | 0 |
| K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2004-11-05 | 165 | 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