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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 K251611
Device Name Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/27/2025
Decision Date 06/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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