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FDA 510(k)

RhythmStar System (SL)

K-Number: K250793 · 2026-04-21

ApplicantRhythMedix, LLC
Decision Date2026-04-21
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RhythmStar System (SL) is the device name listed in this FDA 510(k) record. The listed applicant is RhythMedix, LLC. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K250793. 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 RhythmStar System (SL)?

RhythmStar System (SL) is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is RhythMedix, LLC. The 510(k) number is K250793.

When did RhythmStar System (SL) receive FDA 510(k) clearance?

RhythmStar System (SL) received FDA 510(k) clearance on 2026-04-21, under 510(k) number K250793.

Who is the listed applicant for RhythmStar System (SL)?

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

What is the FDA product code for RhythmStar System (SL)?

The FDA product code for RhythmStar System (SL) is QYX.

Other records listing RhythMedix, LLC 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.

K233584RhythmStar 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.

K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.K240653SmartCardia 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

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

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