FDA applicant
Trek Diagnostic Systems, Inc.
FDA records 69 decisions for Trek Diagnostic Systems, Inc. (Cleveland, OH) from 1979 to 2014: 68 510(k) clearances and 1 original PMA approval. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and NGZ (Susceptibility Test Plate, Antifungal). Its devices cite 1 predicate, 0 of them its own earlier devices. 13 recalls are linked to its devices, 9 Class I.
FDA’s records also spell it “Trek Diagnostic Systems, Ltd.”, “Trek Diagnostic Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trek Diagnostic Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Trek Diagnostic Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Trek”
FDA records each applicant name separately; these may or may not be the same firm.