510(k) Report

FDA product code · Clinical toxicology

Gas Liquid Chromatography, Barbiturate

DMFClass II21 CFR 862.3150510(k) required0 decisions0 recalls

0 FDA decisions. 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 DMF 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 · DMF

FDA has decided no DMF device since 2007.

Median 510(k) review, days · DMF

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

Recalls per year · DMF

No recall names DMF since 2007.

Adverse event reports per year · DMF

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DMF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DMF? 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 862.3150.

DJN Mercury Dithiazone, Colorimetry, BarbiturateDKX Thin Layer Chromatography, BarbiturateDIS Enzyme Immunoassay, BarbituratePUY Test, Barbiturate, Employment And Insurance…PTH Test, Barbiturate, Over The CounterDLX Hemagglutination Inhibition, BarbiturateDKN Radioimmunoassay, BarbiturateKZY High Pressure Liquid Chromatography, Barbiturate