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FDA 510(k)

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

K-Number: K241179 · 2025-07-11

ApplicantVivaQuant, Inc.
Decision Date2025-07-11
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is the device name listed in this FDA 510(k) record. The listed applicant is VivaQuant, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K241179. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is VivaQuant, Inc.. The 510(k) number is K241179.

When did Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) receive FDA 510(k) clearance?

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) received FDA 510(k) clearance on 2025-07-11, under 510(k) number K241179.

Who is the listed applicant for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

The FDA 510(k) record lists VivaQuant, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

The FDA product code for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is QYX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05825417Pulmonary Hypertension: Intensification and Personalisation of Combination RxACTIVE_NOT_RECRUITINGNCT05960175Impact of Patient Involvement in Alerts Management of Telemonitoring CPAPACTIVE_NOT_RECRUITINGNCT07752940Smartphone Based-PPG Assessment of REconversion in Persistent Atrial FibrillationNOT_YET_RECRUITING

Other records listing VivaQuant, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemK183704RX-1 Rhythm Express Remote Cardiac Monitoring System

Related Devices (Code: QYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250793RhythmStar System (SL)RhythMedix, LLCK240653SmartCardia 7L Platform (MCT)Smartcardia SAK240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.K233584RhythmStar SystemRhythMedix, LLCK162956NOWCARDIO SYSTEMContex International Technologies (Canada), Inc.K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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