Data / Medical devices / United States / Rhythmedix
Rhythmedix: FDA-registered device maker in Mount Laurel, NJ, United States, 3 510(k) clearances
Rhythmedix is registered with the FDA (registration 3011265784) in Mount Laurel, NJ, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011265784
- Address
- Horizon Corporate Center 5000 Atrium Way, Suite 1, Mount Laurel, NJ, United States, 08054
- Owner or operator
- Rhythmedix (10047405)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 25, 2014
- Registered through
- 2027
- Brand names listed
- BodyGuardian ONE, RhythmStar, RhythmStar System, RhythmStar System (SL)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Outpatient Cardiac Telemetry | QYX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | K250793 | RhythmStar System (SL) | QYX | Substantially Equivalent | RhythMedix, LLC | accessdata.fda.gov |
| July 8, 2024 | K233584 | RhythmStar System | QYX | Substantially Equivalent | RhythMedix, LLC | accessdata.fda.gov |
| August 5, 2014 | K141813 | RHYTHMSTAR SYSTEM | DXH | Substantially Equivalent | RhythMedix, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Outpatient Cardiac Telemetry
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.