RhythmStar System (SL)— 510(k) K250793
Substantially EquivalentRhythMedix, LLC
FDA 510(k) clearance K250793 for RhythmStar System (SL), Substantially Equivalent on 2026-04-21. Applicant: RhythMedix, LLC. Device class: 2.
Summary
RhythMedix's RhythmStar System (SL) is filed under product code QYX (Outpatient Cardiac Telemetry). The record doesn't explain the SL designation in the name.
Class II, 21 CFR 870.1025. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
RhythMedix filed from Mt. Laurel, New Jersey. Review took 403 calendar days (March 14, 2025 to April 21, 2026).
Clearance details
- Applicant
- RhythMedix, LLC
- Product code
- Product code QYX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Laurel, NJ, US
Recent devices under product code QYX
view allMore clearances from RhythMedix, LLC
view allAdverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.