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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K250312
Device Name Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Sirisha Kommana
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Sirisha Kommana
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/03/2025
Decision Date 07/02/2025
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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