FDA product code · Cardiovascular

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

DRIClass I21 CFR 870.2620510(k) exempt4 decisions since 19800 recalls

FDA lists DRI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 870.9 applies, such as a new intended use or a different fundamental technology. 4 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, cardiovascular panel

Twenty years of DRI 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 · DRI

FDA has decided no DRI device since 2007.

Median 510(k) review, days · DRI

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

Recalls per year · DRI

No recall names DRI since 2007.

Adverse event reports per year · DRI

1in 2019

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
2010	—	1
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — DRI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DRI? 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

Monitor, Line Isolation

What has FDA decided in DRI lately?