FDA product code · Cardiovascular

Cardiograph, Apex (Vibrocardiograph)

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

DQHClass II21 CFR 870.2310510(k) required1 decision since 19980 recalls

1 FDA decision since 1998. 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 DQH 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 · DQH

FDA has decided no DQH device since 2007.

Median 510(k) review, days · DQH

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

Recalls per year · DQH

No recall names DQH since 2007.

Adverse event reports per year · DQH

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

Planning a device in DQH? 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

Cardiograph, Apex (Vibrocardiograph)

What has FDA decided in DQH lately?