510(k) Report

Devices descending from K092846

30 later devices reach Airvo Series Humidifiers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+1K103316FlowrestVapotherm, Inc.20113—
+2K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+2K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+3K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+3K233707HFT150Invent Medical Corporation20240—
+3K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+3K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+3K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+3K203357HVT 2.0Vapotherm, Inc.20211—
+3K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+3K180474TNI softFlow 50Tni Medical AG20180—
+4K254078HVT 2.0Vapotherm, Inc.20260—
+4K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+4K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+4K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+4K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+4K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+4K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+4K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+4K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+4K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+5K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+5K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+5K242931HFT750UMekics Co., Ltd.20250—
+5K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+5K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+5K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+5K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+6K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—