FDA product code · Cardiovascular

Densitometer

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

DXMClass II21 CFR 870.1450510(k) required2 decisions since 19780 recalls

2 FDA decisions since 1978. 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, cardiovascular panel

Twenty years of DXM 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 · DXM

FDA has decided no DXM device since 2007.

Median 510(k) review, days · DXM

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

Recalls per year · DXM

No recall names DXM since 2007.

Adverse event reports per year · DXM

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

Planning a device in DXM? 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

Densitometer

What has FDA decided in DXM lately?