510(k) Report

Devices descending from K072592

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103395Performax Total Face MaskRespironics, Inc.20110—
+1K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+1K092043Bipap Synchrony 2Respironics, Inc.20094—
+1K091271Respironics Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+2K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+2K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—