510(k) Report

Devices descending from K072588

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232836Family of DIMAR DMAX NIV masksDimar S.P.A.20240—
+1K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+1K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+2K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+2K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+2K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—