FDA applicant
Datrix
FDA records 5 decisions for Datrix (Escondido, CA) from 1992 to 2005: 5 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Datrix’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Datrix since 2007.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Datrix’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 “Datrix”
FDA records each applicant name separately; these may or may not be the same firm.