Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Trophy — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
168 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193390 | CS Model+ | Trophy | 2020-04-02 | 118 | 0 |
| K200183 | CS 9600 | Trophy | 2020-03-13 | 49 | 1 |
| K181136 | CS 9600 | Trophy | 2018-05-24 | 24 | 1 |
| K173622 | CS Imaging | Trophy | 2018-01-16 | 53 | 0 |
| K151087 | CS 8100SC, CS8100SC Access | Trophy | 2015-08-21 | 120 | 0 |
| K151837 | CS 3D Imaging | Trophy | 2015-08-19 | 44 | 0 |
| K141607 | DENTAL IMAGING SOFTWARE | Trophy | 2014-09-18 | 94 | 0 |
| K133406 | CS 8100 3D | Trophy | 2014-03-14 | 128 | 1 |
| K120975 | CS 8100 CS 8100 ACCESS | Trophy | 2012-06-22 | 81 | 1 |
| K113419 | CS IMAGING | Trophy | 2012-02-16 | 90 | 0 |
| K103659 | CS 9300, CS 9300C | Trophy | 2011-08-18 | 246 | 0 |
| K093478 | KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM | Trophy | 2010-04-26 | 168 | 0 |
| K082972 | KODAK 9500 | Trophy | 2008-12-05 | 60 | 0 |
| K080889 | KODAK 9000C EXTRAORAL IMAGING SYSTEM | Trophy | 2008-04-29 | 29 | 0 |
| K073435 | KODAK 9000, KODAK 9000 3D | Trophy | 2008-02-11 | 67 | 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