FDA product code QYX: Outpatient Cardiac Telemetry
QYX is the FDA product code for outpatient cardiac telemetry. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under QYX, 5 in the last five years, from 12 different applicants. The average 510(k) review took 173 days (median 155); 366 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Outpatient Cardiac Telemetry |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QYX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 219 |
| 2024 | 3 | 258 |
| 2025 | 1 | 438 |
| 2026 | 1 | 403 |
Compare with all 510(k) review times · Search every QYX clearance
Top QYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corventis, Inc. | 4 | 2014-02-06 |
| Cardionet, Inc. | 4 | 2010-04-08 |
| RhythMedix, LLC | 2 | 2026-04-21 |
| iRhythm Technologies, Inc. | 2 | 2024-10-21 |
| Infobionic, Inc. | 2 | 2016-03-11 |
7 more applicants have QYX clearances. See the full list in Caduvo.
Most recent QYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250793 | RhythMedix, LLC | RhythmStar System (SL) | 2026-04-21 | 403 |
| K241179 | VivaQuant, Inc. | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | 2025-07-11 | 438 |
| K240653 | Smartcardia SA | SmartCardia 7L Platform (MCT) | 2024-10-31 | 238 |
| K240029 | iRhythm Technologies, Inc. | Zio AT® device (A100A1001) | 2024-10-21 | 291 |
| K233584 | RhythMedix, LLC | RhythmStar System | 2024-07-08 | 244 |
Recalls for QYX devices
openFDA lists no recalls for product code QYX.
Frequently asked questions
What is FDA product code QYX?
QYX is the FDA product code for outpatient cardiac telemetry. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is QYX?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYX?
Across 21 cleared submissions the average was 173 days from receipt to decision (median 155).
Which companies have the most QYX clearances?
Corventis, Inc. (4); Cardionet, Inc. (4); RhythMedix, LLC (2); iRhythm Technologies, Inc. (2); Infobionic, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QYX
- Run a recall and safety report across every QYX manufacturer
- Watch product code QYX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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