510(k) Report

Devices descending from K022465

19 later devices reach Modification to Nasal-Aire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140980TI Nasal MaskRespironics, Inc.20152Class I
+1K1034343B Flex-Lite3B Products, LLC20110—
+1K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+1K080516Lamin AirRemgenic, LLC20080—
+1K042130Aura Cpap Patient InterfaceAeiomed, Inc.20048—
+1K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc.20041—
+1K031896Nasal-Air Critical CareInnomed Technologies20040—
+1K031883Lyra Nasal MaskSensor Medics Corp.20033—
+2K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+2K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+2K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+2K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC20060—
+2K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—
+3K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+3K150365Cloud9 SystemInsleep Technologies, LLC20150—
+3K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+3K132127Transcend AutoSomnetics International, Inc.20131—
+3K121374ZI BlowerDeshum Medical20131—
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—