FDA product code QYW: Hospital Cardiac Telemetry
QYW is the FDA product code for hospital cardiac telemetry. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under QYW, from 2 different applicants. The average 510(k) review took 414 days (median 414).
Definition
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 display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Hospital Cardiac Telemetry |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every QYW clearance
Top QYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remote Diagnostic Technologies , Ltd. | 1 | 2014-08-14 |
| Cardiac Telecom Corp. | 1 | 1995-06-05 |
Most recent QYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133973 | Remote Diagnostic Technologies , Ltd. | TEMPUS PRO WITH ENHANCED FEATURES | 2014-08-14 | 231 |
| K934913 | Cardiac Telecom Corp. | HEARTRAC ECG MONITORING SYSTEM | 1995-06-05 | 598 |
Recalls for QYW devices
openFDA lists no recalls for product code QYW.
Frequently asked questions
What is FDA product code QYW?
QYW is the FDA product code for hospital cardiac telemetry. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is QYW?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYW?
Across 2 cleared submissions the average was 414 days from receipt to decision (median 414).
Which companies have the most QYW clearances?
Remote Diagnostic Technologies , Ltd. (1); Cardiac Telecom Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYW
- Run a recall and safety report across every QYW manufacturer
- Watch product code QYW 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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