FDA product code · Cardiovascular

System, Signal Isolation

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

DRJClass I21 CFR 870.2600510(k) exempt4 decisions since 19770 recalls

FDA lists DRJ 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 1977. 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 DRJ 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 · DRJ

FDA has decided no DRJ device since 2007.

Median 510(k) review, days · DRJ

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

Recalls per year · DRJ

No recall names DRJ since 2007.

Adverse event reports per year · DRJ

3in 2025

2007high 7 (2020) · low 0 (2007)2025

MAUDE reports naming product code DRJ, 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	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	4
2020	—	7
2021	—	3
2022	—	4
2023	—	3
2024	—	2
2025	—	3
2026	—	—

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

Planning a device in DRJ? 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

System, Signal Isolation

What has FDA decided in DRJ lately?