FDA product code · Cardiovascular

Injector, Indicator

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

DXLClass II21 CFR 870.1660510(k) required3 decisions since 19760 recalls

3 FDA decisions since 1976. 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 DXL 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 · DXL

FDA has decided no DXL device since 2007.

Median 510(k) review, days · DXL

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

Recalls per year · DXL

No recall names DXL since 2007.

Adverse event reports per year · DXL

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

Planning a device in DXL? 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

Injector, Indicator

What has FDA decided in DXL lately?