510(k) Report

Devices descending from K101129

3 later devices reach Esprit Ventilator with AF531 SE Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+1K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+1K150638AF541 SE Full Face MaskRespironics, Inc.20151—