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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 K262268
Device Name Optiflow Oxygen Kit (AA484J)
Applicant
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Applicant Contact Amelia Rosario
Correspondent
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Amelia Rosario
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/06/2026
Decision Date 08/27/2026
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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