FDA product code · Cardiovascular

Hospital Cardiac Telemetry

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

QYWClass II21 CFR 870.1025510(k) required2 decisions since 19950 recalls

2 FDA decisions since 1995. No recall names this code. The most-cited predicate is K934913, named by 1 later device.

Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and…

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 QYW 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 · QYW

1in 2014

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QYW

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

Recalls per year · QYW

No recall names QYW since 2007.

Adverse event reports per year · QYW

No MAUDE report names QYW since 2007.

View these four charts as a table

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

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

Planning a device in QYW? 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

Related product codes

Other codes under 21 CFR 870.1025.

MLD Monitor, St Segment With Alarm MHX Monitor, Physiological, Patient (With…QYX Outpatient Cardiac Telemetry MXD Recorder, Event, Implantable Cardiac, (With…DSI Detector And Alarm, Arrhythmia

Hospital Cardiac Telemetry

Which predicates do QYW devices cite most?

Which QYW devices have the deepest lineage?

What has FDA decided in QYW lately?

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