RhythmStar System (SL)— 510(k) K250793

Substantially Equivalent

RhythMedix, LLC

FDA 510(k) clearance K250793 for RhythmStar System (SL), Substantially Equivalent on 2026-04-21. Applicant: RhythMedix, LLC.

Clearance details

Applicant: RhythMedix, LLC
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2025-03-14
Decision date: 2026-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.