510(k) Report

Devices descending from K012207

26 later devices reach Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+1K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc.20041—
+1K031935Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Tiara Medical Systems, Inc.200423—
+2K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+2K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc.200521—
+3K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation200620—
+4K132887Airfit N10Resmed, Ltd.20137Class I
+4K120463Mojo, VerasealSleepnet Corporation20124Class I
+4K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+4K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+5K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+5K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+5K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+5K153673AirFit N20Resmed, Ltd.20166—
+5K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+6K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+6K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+6K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+6K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+6K161978AirFit N20Resmed, Ltd.20165Class I
+6K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+7K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+7K171212AirFit N20Resmed, Ltd.20173Class I
+8K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+8K180497Scone MaskResmed, Ltd.20181—
+9K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—