510(k) Report

Devices descending from K952292

134 later devices reach Puritan-Bennett Companion Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+9K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+9K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+9K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+9K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+9K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+9K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+9K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+9K200565GalapogosResmed Corp20213—
+9K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+9K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+9K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+9K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+9K180619BongoInnomed Healthscience, Inc.20181—
+9K153061Juno VPAP ST-AResmed, Ltd.20163—
+9K140279S9 GreenhillsResmed, Ltd.20142—
+9K122324Vpap S-aResmed, Ltd.20120—
+10K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+10K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+10K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+10K242931HFT750UMekics Co., Ltd.20250—
+10K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+10K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+10K241216myAirResmed Corp20242—
+10K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+10K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+10K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+10K213169BPAP SystemBMC Medical Co., Ltd.20220—
+10K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+10K161492Juno VPAP ST-AResmed, Ltd.20171—
+11K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+11K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+11K250624myAirResmed Corp20251—
+12K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—