FDA product code · Clinical toxicology

Reagents, Test, Tetrahydrocannabinol

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

DKEClass II21 CFR 862.3870510(k) required12 decisions since 19800 recalls

12 FDA decisions since 1980. 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 DKE 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 · DKE

FDA has decided no DKE device since 2007.

Median 510(k) review, days · DKE

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

Recalls per year · DKE

No recall names DKE since 2007.

Adverse event reports per year · DKE

No MAUDE report names DKE 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 — DKE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DKE? 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

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Reagents, Test, Tetrahydrocannabinol

Which DKE devices have the deepest lineage?

What has FDA decided in DKE lately?

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