RhythmStar System— 510(k) K233584

Name: FDA 510(k) clearance K233584
Creator: U.S. Food and Drug Administration
Published: 2024-07-08

Substantially Equivalent

RhythMedix, LLC

FDA 510(k) clearance K233584 for RhythmStar System, Substantially Equivalent on 2024-07-08. Applicant: RhythMedix, LLC. Device class: 2.

Clearance details

Applicant: RhythMedix, LLC
Product code: Code QYX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2023-11-07
Decision date: 2024-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYX

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K250793 — RhythmStar System (SL)2026-04-21
K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)2025-07-11
K240653 — SmartCardia 7L Platform (MCT)2024-10-31
K240029 — Zio AT® device (A100A1001)2024-10-21
K162956 — NOWCARDIO SYSTEM2017-09-22

More clearances from RhythMedix, LLC

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K141813 — RHYTHMSTAR SYSTEM2014-08-05

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.