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21 FDA 510(k) clearances · Product code

FDA profile

Official device name

Outpatient Cardiac Telemetry

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1025

Medical specialty

Cardiovascular

FDA 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.

Adverse events (MAUDE)

2023: 74 · 2024: 400 · 2025: 110 · 2026: 54
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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