510(k) Report

Devices descending from K132887

7 later devices reach Airfit N10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153673AirFit N20Resmed, Ltd.20166—
+2K161978AirFit N20Resmed, Ltd.20165Class I
+3K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+3K171212AirFit N20Resmed, Ltd.20173Class I
+4K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+4K180497Scone MaskResmed, Ltd.20181—
+5K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—