510(k) Report

Devices descending from K131982

5 later devices reach Remstar Auto a-Flex HT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+1K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+2K251770SleepRes PAP SystemSleepres, Inc.20250—
+2K213169BPAP SystemBMC Medical Co., Ltd.20220—
+2K212263Luna G3 BPAP System3B Medical, Inc.20220—