510(k) Report

Devices descending from K915460

117 later devices reach Heated Respiratory Humidifier HC100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+9K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+9K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+9K242931HFT750UMekics Co., Ltd.20250—
+9K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+9K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+9K241216myAirResmed Corp20242—
+9K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+9K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+9K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+9K213169BPAP SystemBMC Medical Co., Ltd.20220—
+9K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+9K161492Juno VPAP ST-AResmed, Ltd.20171—
+10K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+10K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+10K250624myAirResmed Corp20251—
+11K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—