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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K252676
Device Name The Circadia C300 System (C300)
Applicant
Circadia Health, Inc.
507 S Douglas St.
El Segundo,  CA  90245
Applicant Contact Timo Lauteslager
Correspondent
Circadia Health, Inc.
507 S Douglas St.
El Segundo,  CA  90245
Correspondent Contact Erhan Ilhan
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received08/25/2025
Decision Date 02/03/2026
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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