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510(k) K253479

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) by Fisher &Paykel Healthcare , Ltd. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
October 14, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Fisher &Paykel Healthcare , Ltd.

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  • K233643 — F&P Airvo 3 NIV (PT311US) (August 9, 2024)
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  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)
  • K231956 — F&P Optiflow+ Duet Nasal Cannula (February 7, 2024)
  • K223684 — F&P 820 Humidification System (September 5, 2023)

Other clearances for product code BTT

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  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)