Cleared Traditional

K233584 - RhythmStar System

K233584 is an FDA 510(k) clearance for RhythmStar System, manufactured by RhythMedix, LLC. The device is a Class 2 Cardiovascular device with product code QYX cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K233584 · RhythMedix, LLC · Cardiovascular device
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Jul 2024
Decision
244d
Days
Class 2
Risk

K233584 is an FDA 510(k) clearance for the RhythmStar System. Classified as Outpatient Cardiac Telemetry (product code QYX), Class II - Special Controls.

Submitted by RhythMedix, LLC (Mt. Laurel, US). The FDA issued a Cleared decision on July 8, 2024 after a review of 244 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all RhythMedix, LLC devices

FDA 510(k) Submission Details - K233584

510(k) Number K233584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 125d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QYX Device Classification - Class 2, Special Controls

Product Code QYX Outpatient Cardiac Telemetry
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QYX Outpatient Cardiac Telemetry

All 20
Devices cleared under the same product code (QYX) and FDA review panel - the closest regulatory comparables to K233584.
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K241179 · Vivaquant, Inc. · Jul 2025
SmartCardia 7L Platform (MCT)
K240653 · Smartcardia SA · Oct 2024
Zio AT® device (A100A1001)
K240029 · iRhythm Technologies, Inc. · Oct 2024
NOWCARDIO SYSTEM
K162956 · Contex International Technologies (Canada), Inc. · Sep 2017
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
K170565 · Lifewatch Services, Inc. · Aug 2017
Zio AT ECG Monitoring System
K163512 · iRhythm Technologies, Inc. · Jun 2017