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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K252173
Device Name F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
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 Number868.5895
Classification Product Code
CBK  
Date Received07/11/2025
Decision Date 09/10/2025
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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