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Fisher & Paykel Healthcare, Ltd.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories7
Latest FDA decision2025-12-19
TypeNumberDevice NameCodeDateActions
510(k) K253479 Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT2025-12-19 View
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 JunSGR2025-11-19 View
510(k) K252173 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 FullCBK2025-09-10 View
510(k) K243917 F&P Optiflow Air/Oxygen Flow SourceBZR2025-07-14 View
510(k) K251611 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)BTT2025-06-25 View
510(k) K234053 F&P Optiflow Flow DiverterCBP2024-08-09 View
510(k) K233643 F&P Airvo 3 NIV (PT311US)MNT2024-08-09 View
510(k) K234058 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT2024-08-08 View
510(k) K233821 F&P Optiflow Oxygen Kit (AA451J)BTT2024-06-13 View
510(k) K231956 F&P Optiflow+ Duet Nasal CannulaBTT2024-02-07 View
510(k) K223684 F&P 820 Humidification SystemBTT2023-09-05 View
510(k) K221436 F&P 950 Accessory Breathing Circuit KitsBZD2023-06-29 View
510(k) K223696 F&P Solo Mask RangeBZD2023-05-17 View
510(k) K222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeBTT2023-04-06 View
510(k) K212031 F&P 850 AirSpiral Adult NIV and NHF Circuit KitBTT2022-04-22 View
510(k) K212371 F&P Evora Full Face MaskBZD2022-03-18 View
510(k) K211096 Optiflow Oxygen KitBTT2022-01-28 View
510(k) K203449 F&P Visairo NIV Mask RangeCBK2021-04-14 View
510(k) K201723 F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingBTT2021-03-16 View
510(k) K200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab ModelBZD2020-06-02 View

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