510(k) Report

Devices descending from K153673

6 later devices reach AirFit N20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161978AirFit N20Resmed, Ltd.20165Class I
+2K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+2K171212AirFit N20Resmed, Ltd.20173Class I
+3K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+3K180497Scone MaskResmed, Ltd.20181—
+4K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—