510(k) Report

Devices descending from K091319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+1K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+2K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+2K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+2K122769Remstar SERespironics, Inc.20123Class I
+2K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+2K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+2K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+3K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+3K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+3K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+3K130077Remstar SERespironics, Inc.20132Class I
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K251770SleepRes PAP SystemSleepres, Inc.20250—
+4K213169BPAP SystemBMC Medical Co., Ltd.20220—
+4K212263Luna G3 BPAP System3B Medical, Inc.20220—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+6K233452Vivo 45 LSBreas Medical AB202501