FDA product code · Cardiovascular

Adaptor, Lead Switching, Electrocardiograph

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

DRWClass II21 CFR 870.2350510(k) required8 decisions since 19760 recalls

8 FDA decisions since 1976. No recall names this code. The most-cited predicate is K033513, named by 19 later devices.

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 DRW 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 · DRW

FDA has decided no DRW device since 2007.

Median 510(k) review, days · DRW

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

Recalls per year · DRW

No recall names DRW since 2007.

Adverse event reports per year · DRW

1in 2017

2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code DRW, 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	—	2
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in DRW? 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

Adaptor, Lead Switching, Electrocardiograph

Which predicates do DRW devices cite most?

Which DRW devices have the deepest lineage?

What has FDA decided in DRW lately?