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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 K254226
Device Name PulseAPI SmartWatch
Applicant
PulseAI, Ltd.
58 Howard St.
Belfast,  GB BT1 6PL
Applicant Contact Alan Kennedy
Correspondent
PulseAI, Ltd.
58 Howard St.
Belfast,  GB BT1 6PL
Correspondent Contact Alan Kennedy
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/29/2025
Decision Date 10/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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