510(k) Report

FDA applicant

Datrix

Escondido, CA5 decisions1992–20051 recall

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

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

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Datrix by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Datrix”

FDA records each applicant name separately; these may or may not be the same firm.