510(k) Report

Devices descending from K992969

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

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