FDA product code · Cardiovascular

Transducer, Vessel Occlusion

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

DXPClass II21 CFR 870.2890510(k) required2 decisions since 19810 recalls

2 FDA decisions since 1981. 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 DXP 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 · DXP

FDA has decided no DXP device since 2007.

Median 510(k) review, days · DXP

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

Recalls per year · DXP

No recall names DXP since 2007.

Adverse event reports per year · DXP

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

Planning a device in DXP? 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

Transducer, Vessel Occlusion

What has FDA decided in DXP lately?