510(k) Report

Devices descending from K961915

37 later devices reach Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113—
+1K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.20074Class I
+1K023683Multi-Strap Full Face MaskEngineered Medical Systems20030—
+1K0207597600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640…Hans Rudolph, Inc.200226—
+2K193206WiZARD 510 Nasal MaskApex Medical Corp.20200—
+2K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.20191—
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+2K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+2K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+2K072755Galemed Cpap MaskGalemed Corp.20070—
+2K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc.200521—
+2K0308227600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksHans Rudolph, Inc.20033—
+3K243023WiZARD 520 Full Face MaskWellell, Inc.20250—
+3K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+3K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—
+3K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation200620—
+3K052249UtopiaRespcare, Inc.20050—
+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—