510(k) Report

Devices descending from K123789

8 later devices reach Swift FX Nano through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132887Airfit N10Resmed, Ltd.20137Class I
+2K153673AirFit N20Resmed, Ltd.20166—
+3K161978AirFit N20Resmed, Ltd.20165Class I
+4K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+4K171212AirFit N20Resmed, Ltd.20173Class I
+5K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+5K180497Scone MaskResmed, Ltd.20181—
+6K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—