Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trek Diagnostic Systems — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | 2014-01-31 | 127 | 0 |
| K112276 | VIZION | Trek Diagnostic Systems | 2011-11-16 | 99 | 0 |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | 2011-11-08 | 151 | 0 |
| K103532 | AUTOREADER 2 | Trek Diagnostic Systems | 2011-08-26 | 268 | 0 |
| K103456 | THE SENSITITRE AIM | Trek Diagnostic Systems | 2011-06-22 | 210 | 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