Data / Medical devices / Outpatient Cardiac Telemetry
Outpatient Cardiac Telemetry (QYX): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Outpatient Cardiac Telemetry (product code QYX, Class 2, 21 CFR 870.1025). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on April 21, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QYX
- Device class
- 2
- Regulation
- 870.1025
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Switzerland | 1 |
| India | 1 |
| Poland | 1 |
Makers of Outpatient Cardiac Telemetry
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Irhythm Technologies, Inc. | San Francisco, CA, United States | Specification developer | 2 | October 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rhythmedix | Mount Laurel, NJ, United States | Complaint file establishment, Manufacturer | 2 | April 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| iRhythm Technologies, Inc. | Cypress, CA, United States | Manufacturer | 2 | October 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Applied Cardiac Systems, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Infobionic, Inc. | Burleson, TX, United States | Complaint file establishment, Specification developer | 1 | March 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | February 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| Smartcardia SA | Lausanne Vaud, Switzerland | Complaint file establishment, Manufacturer | 1 | October 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| VivaQuant, Inc | Arden Hills, MN, United States | Manufacturer | 1 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | Rochester, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals India Private Limited | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicalgorithmics S.A. | WARSAW Mazowieckie, Poland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.