Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trek Diagnostic Systems, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
205 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110583 | SENSITITRE OPTIREAD | Trek Diagnostic Systems, Ltd. | 2011-09-22 | 205 | 0 |
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE ( | Trek Diagnostic Systems, Ltd. | 2011-08-18 | 87 | 1 |
| K110331 | SENSITITRE AIM (TM) | Trek Diagnostic Systems, Ltd. | 2011-04-27 | 83 | 0 |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, ( | Trek Diagnostic Systems, Ltd. | 2010-02-25 | 83 | 0 |
| K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Ltd. | 2009-12-16 | 128 | 0 |
| K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Ltd. | 2006-10-13 | 35 | 0 |
| K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUS | Trek Diagnostic Systems, Ltd. | 2004-07-27 | 49 | 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