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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K253030
Device Name Capnostream™35 Portable Respiratory Monitor (PM35MN)
Applicant
Covidien, LLC
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Shannon Ryan
Correspondent
Covidien, LLC
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Shannon Ryan
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received09/19/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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