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510(k) K250651

OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun by Fisher &Paykel Healthcare , Ltd. — Product Code SGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2025
Date Received
March 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Noninvasive Positive Airway Pressure System, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.

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  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)
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Other clearances for product code SGR

  • K251165 — Saans (F4-01-00-000-000) (January 6, 2026)