510(k) Report

Devices descending from K070328

59 later devices reach Bipap Synchrony with Avaps through their predicates, nearest generation first.

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