FDA product code · Clinical toxicology

Gas Chromatography, Methadone

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

DMBClass II21 CFR 862.3620510(k) required1 decision since 19910 recalls

1 FDA decision since 1991. No recall names this code.

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 DMB 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 · DMB

FDA has decided no DMB device since 2007.

Median 510(k) review, days · DMB

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

Recalls per year · DMB

No recall names DMB since 2007.

Adverse event reports per year · DMB

No MAUDE report names DMB since 2007.

View these four charts as a table

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

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

Planning a device in DMB? 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

Related product codes

Other codes under 21 CFR 862.3620.

PVE Test, Methadone, Employment And Insurance…DNT Liquid Chromatography, Methadone DPP Free Radical Assay, Methadone DJR Enzyme Immunoassay, Methadone PTG Test, Methadone, Over The Counter DKR Thin Layer Chromatography, Methadone DIW Hemagglutination Inhibition, Methadone

Gas Chromatography, Methadone

What has FDA decided in DMB lately?

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