FDA product code · Clinical toxicology

Test System, For Drugs Of Abuse

Name: FDA decisions, review times, recalls and adverse event reports for product code MGX
Creator: 510(k) Report

MGXClass IIIPMA required1 decision since 19941 recall

1 FDA decision since 1994. 1 recall names this code; it is not Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical toxicology panel

Twenty years of MGX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MGX

FDA has decided no MGX device since 2007.

Median 510(k) review, days · MGX

Too few MGX 510(k)s in any year since 2007 to give a median.

Recalls per year · MGX

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGX

1in 2017

2007high 8 (2008) · low 0 (2007)2025

MAUDE reports naming product code MGX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	8
2009	—	0	1
2010	—	0	2
2011	—	0	0
2012	—	0	0
2013	—	0	2
2014	—	1	1
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in MGX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Test System, For Drugs Of Abuse

What has FDA decided in MGX lately?

What has been recalled in MGX lately?