510(k) Report

Devices descending from K153563

6 later devices reach AirFit F20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+1K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+1K170924AirFit F20Resmed, Ltd.20183Class I
+2K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+2K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+3K261262Altis Full Face MaskRespironics, Inc.20260—