Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trek Diagnostic Systems, Inc. — Predicate Candidate Screening
56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
109 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2010-02-17 | 63 | 0 |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2009-06-04 | 59 | 1 |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2009-03-24 | 109 | 0 |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMI | Trek Diagnostic Systems, Inc. | 2009-03-06 | 326 | 0 |
| K081520 | SENSITITRE VIZION | Trek Diagnostic Systems, Inc. | 2008-10-24 | 147 | 0 |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2008-03-20 | 85 | 0 |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2008-03-13 | 85 | 0 |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2008-01-22 | 48 | 9 |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND | Trek Diagnostic Systems, Inc. | 2006-12-20 | 89 | 0 |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMON | Trek Diagnostic Systems, Inc. | 2006-11-09 | 49 | 0 |
| K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2006-11-01 | 42 | 0 |
| K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2006-10-26 | 38 | 0 |
| K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2006-10-20 | 38 | 0 |
| K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2006-09-11 | 56 | 0 |
| K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC P | Trek Diagnostic Systems, Inc. | 2006-08-31 | 31 | 0 |
| K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REM | Trek Diagnostic Systems, Inc. | 2006-05-16 | 55 | 0 |
| K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2006-01-20 | 60 | 0 |
| K052323 | VERSATREK MYCO PZA KIT | Trek Diagnostic Systems, Inc. | 2006-01-19 | 147 | 0 |
| K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2005-09-21 | 50 | 0 |
| K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2004-04-26 | 25 | 0 |
| K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2004-04-07 | 29 | 0 |
| K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2004-02-03 | 88 | 0 |
| K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2003-08-29 | 28 | 0 |
| K032306 | VERSATREK | Trek Diagnostic Systems, Inc. | 2003-08-22 | 28 | 2 |
| K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | Trek Diagnostic Systems, Inc. | 2003-07-16 | 61 | 0 |
| K024357 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2003-03-17 | 77 | 0 |
| K024353 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2003-03-06 | 66 | 0 |
| K022656 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2002-10-08 | 60 | 0 |
| K022775 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2002-09-25 | 47 | 0 |
| K021997 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2002-09-25 | 98 | 0 |
| K021627 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2002-06-20 | 34 | 0 |
| K020859 | CEFOTAXIME | Trek Diagnostic Systems, Inc. | 2002-05-15 | 58 | 0 |
| K021339 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE | Trek Diagnostic Systems, Inc. | 2002-05-09 | 63 | 0 |
| K020762 | GATIFLOXIN | Trek Diagnostic Systems, Inc. | 2002-05-09 | 63 | 0 |
| K014259 | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2002-03-26 | 90 | 0 |
| K014258 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2002-02-19 | 55 | 0 |
| K013925 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUS | Trek Diagnostic Systems, Inc. | 2001-12-21 | 37 | 0 |
| K013580 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUS | Trek Diagnostic Systems, Inc. | 2001-12-12 | 44 | 0 |
| K013075 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2001-11-26 | 73 | 0 |
| K013368 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-11-20 | 40 | 0 |
| K013195 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY | Trek Diagnostic Systems, Inc. | 2001-11-07 | 43 | 0 |
| K012921 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2001-11-02 | 63 | 0 |
| K012895 | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE | Trek Diagnostic Systems, Inc. | 2001-10-30 | 63 | 0 |
| K991810 | MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST | Trek Diagnostic Systems, Inc. | 2001-10-09 | 866 | 0 |
| K012565 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLA | Trek Diagnostic Systems, Inc. | 2001-09-12 | 34 | 0 |
| K012151 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Trek Diagnostic Systems, Inc. | 2001-08-29 | 50 | 0 |
| K011803 | SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2001-08-15 | 65 | 0 |
| K004045 | SUSCEPTIBILITY TEST PANEL | Trek Diagnostic Systems, Inc. | 2001-03-06 | 67 | 0 |
| K003868 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2001-02-27 | 75 | 0 |
| K003834 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2001-02-23 | 73 | 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