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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K260801
Device Name Sensinel Cardiopulmonary Management (CPM) System
Applicant
Analog Devices
1 Analog Way
Wilmington,  MA  01887
Applicant Contact Sam Rajkumar
Correspondent
Analog Devices
1 Analog Way
Wilmington,  MA  01887
Correspondent Contact Sam Rajkumar
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DPS   DQD   DSB   DXH  
FLL  
Date Received03/11/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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