Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trident S.R.L — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
307 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023-07-10 | 307 | 0 |
| K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident S.R.L | 2020-04-15 | 36 | 0 |
| K182206 | RiX70 DC | Trident S.R.L | 2018-09-13 | 29 | 0 |
| K162619 | I View and Imagen Sensor | Trident S.R.L | 2016-11-04 | 45 | 0 |
| K160386 | ReadeR, VieweR, QuickScan PSP | Trident S.R.L | 2016-03-10 | 28 | 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