Cleared Traditional

RhythmStar System

K233584 · RhythMedix, LLC · Cardiovascular

Jul 2024

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K233584 is an FDA 510(k) clearance for the RhythmStar System, a Outpatient Cardiac Telemetry (Class II — Special Controls, product code QYX), submitted by RhythMedix, LLC (Mt. Laurel, US). The FDA issued a Cleared decision on July 8, 2024, 244 days after receiving the submission on November 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K233584 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2023
Decision Date	July 08, 2024
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QYX — Outpatient Cardiac Telemetry
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025
Definition	Devices Are Intended To Continuously Record And Analyze Electrocardiograms For Automatic Detection And Recording Of Cardiac Electrical Activity In An Outpatient Setting. Detected, Notifiable Events Are Transmitted To The Prescribing Clinician During The Monitoring Period By A 24/7 Attended Analysis Center After Review By A Qualified Individual. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Not For Use For Detection Or Notification Of Hemodynamically Unstable Or Life-threatening Arrhythmias Or Cardiac Events Requiring Urgent Medical Response. Not Intended For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. It Is Not Intended For Monitoring Patients During Cardiac Rehabilitation Outside Of Healthcare Facilities. Devices Are Intended For Prescription Use Only.