510(k) Report

Devices descending from K043382

21 later devices reach TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation200620—
+2K132887Airfit N10Resmed, Ltd.20137Class I
+2K120463Mojo, VerasealSleepnet Corporation20124Class I
+2K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+2K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+3K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+3K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+3K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+3K153673AirFit N20Resmed, Ltd.20166—
+3K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+4K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+4K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+4K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+4K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+4K161978AirFit N20Resmed, Ltd.20165Class I
+4K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+5K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+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—