FDA 510(k)

STAR Apollo Mapping System

K-Number: K253733 · 2025-12-19

Decision Date2025-12-19

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

STAR Apollo Mapping System is a medical device manufactured by Rhythm AI, Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253733. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR Apollo Mapping System?

STAR Apollo Mapping System is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Rhythm AI, Ltd.. The 510(k) number is K253733.

When was STAR Apollo Mapping System approved by the FDA?

STAR Apollo Mapping System received FDA 510(k) clearance on 2025-12-19, under approval number K253733.

What company makes STAR Apollo Mapping System?

STAR Apollo Mapping System is manufactured by Rhythm AI, Ltd..

What is the FDA product code for STAR Apollo Mapping System?

The FDA product code for STAR Apollo Mapping System is DQK.

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Other Devices by Rhythm AI, Ltd.

K240509STAR Apollo Mapping System

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

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.