510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QYXClass II

Outpatient Cardiac Telemetry

21 CFR 870.1025 / Cardiovascular
FDA source (opens on fda.gov)

QYX is the FDA product code for Outpatient Cardiac Telemetry, a class II device type, regulated under 21 CFR 870.1025. FDA's definition for this code reads: "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...". As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYX
Device name
Outpatient Cardiac Telemetry
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.
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
0

Clearances, product code QYX

By decision year
21 clearances under product code QYX with a decision year between 1998 and 2026, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QYX by decision year
YearClearances
19981
20021
20051
20061
20071
20091
20101
20112
20121
20142
20161
20173
20243
20251
20261

Applicants with the most clearances

Product code QYX
Applicants holding the most 510(k) clearances under product code QYX
ApplicantClearances
Cardionet, LLC4
Corventis, Inc.4
Infobionic, Inc.2
Rhythmedix2
iRhythm Technologies, Inc.2
Applied Cardiac Systems1
Cardiac Telecom Corp.1
Contex International Technologies (Canada), Inc.1
Lifewatch Services, Inc.1
Mennen Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code