510(k) Report

Devices descending from K925920

16 later devices reach Total Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992969Respironics Total Face MaskRespironics, Inc.199915—
+2K232836Family of DIMAR DMAX NIV masksDimar S.P.A.20240—
+2K072592Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20076—
+2K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20077—
+3K103395Performax Total Face MaskRespironics, Inc.20110—
+3K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+3K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+3K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+3K092043Bipap Synchrony 2Respironics, Inc.20094—
+3K091271Respironics Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+4K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+4K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+4K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+4K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—