Product code QYX— Cardiovascular
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
- Classification name
- Outpatient Cardiac Telemetry
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Total cleared
- 21
- First cleared
- Most recent
FDA classification definition
“Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.”
Market context for product code QYX
FDA has cleared devices under product code QYX between 1998 and 2026, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2017
- 2016
- 2014
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2005
- 2002
- 1998
Top applicants under product code QYX
Adverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code QYX
- K250793 — RhythmStar System (SL)
- K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
- K240653 — SmartCardia 7L Platform (MCT)
- K240029 — Zio AT® device (A100A1001)
- K233584 — RhythmStar System
- K162956 — NOWCARDIO SYSTEM
- K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
- K163512 — Zio AT ECG Monitoring System
- K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
- K133753 — MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
- K133701 — NUVANT MCT SYSTEM
- K113372 — NUVANT, MOBILC CARDIAC TELEMETRY
- K103706 — THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
- K111917 — NUVANT, MOBILE CARDIAC TELEMETRY
- K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
- K090696 — NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM
- K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
- K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
- K052240 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
- K020632 — ENGUARD REMOTE PATIENT MONITOR
- K982803 — HEARTLINK, MODEL II
Data sourced from openFDA. This site is unofficial and independent of the FDA.