510(k) Report

Devices descending from K121975

25 later devices reach Airvo Humidifier Myairo Humidifier through their predicates, nearest generation first.

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