510(k) Report

Devices descending from K113068

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+1K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+1K122769Remstar SERespironics, Inc.20123Class I
+2K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+2K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+2K130077Remstar SERespironics, Inc.20132Class I
+3K251770SleepRes PAP SystemSleepres, Inc.20250—
+3K213169BPAP SystemBMC Medical Co., Ltd.20220—
+3K212263Luna G3 BPAP System3B Medical, Inc.20220—