510(k) Report

Devices descending from K020777

61 later devices reach Bipap Synchrony Ventilatory Support System with BI-Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+1K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group200759—
+2K090113Breas Vivo 40 SystemBreas Medical AB200923—
+2K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+2K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+3K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+3K183226Care Orchestrator EssenceRespironics, Inc.20190—
+3K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K112754IVENT101Versamed Medical Systems, Ltd.20129—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+3K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+3K103167Stellar 150Resmed Germany, Inc.201120—
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K242931HFT750UMekics Co., Ltd.20250—
+4K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+4K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+4K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K112914Vpap TXResmed, Ltd.20110—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K160481Vivo 60Breas Medical AB201672
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K122324Vpap S-aResmed, Ltd.20120—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—