510(k) Report

Devices descending from K090244

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+1K132013Swift AirResmed, Ltd.20131—
+1K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+1K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+1K123789Swift FX NanoResmed, Ltd.20138—
+1K112489Swift FX BellaResmed, Ltd.20110—
+1K1034343B Flex-Lite3B Products, LLC20110—
+2K150365Cloud9 SystemInsleep Technologies, LLC20150—
+2K132887Airfit N10Resmed, Ltd.20137Class I
+3K153673AirFit N20Resmed, Ltd.20166—
+4K161978AirFit N20Resmed, Ltd.20165Class I
+5K171212AirFit N20Resmed, Ltd.20173Class I
+6K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+6K180497Scone MaskResmed, Ltd.20181—
+7K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—