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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K263380
Device Name STAR Apollo™ Mapping System
Applicant
Rhythm AI, Ltd.
One London Wall, 6th Floor
London,  GB EC2Y 5EB
Applicant Contact Linda D'Abate
Correspondent
Rhythm AI, Ltd.
One London Wall, 6th Floor
London,  GB EC2Y 5EB
Correspondent Contact Linda D'Abate
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/24/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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