510(k) Report

Devices descending from K962517

196 later devices reach Model 7700 Quantum Pressure Support Ventilator PSV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992530Bipap Synchrony HCRespironics, Inc.200092—
+1K984407Bipap Harmony S/T, Model 1001445Respironics, Inc.1999115—
+2K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group200759—
+2K063540Bipap AutosvRespironics, Inc.200713—
+2K063533Bipap SynchronyRespironics, Inc.200730—
+2K053168Bipap FocusRespironics (Ireland) Limited2006111
+2K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc.2002102—
+2K012323Bipap Synchrony Ventilatory Support SystemRespironics, Inc.200191—
+3K093094Vela VentilatorCardinal Health 207, Inc.20102—
+3K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group20090Class I
+3K092043Bipap Synchrony 2Respironics, Inc.20094—
+3K090113Breas Vivo 40 SystemBreas Medical AB200923—
+3K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+3K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+3K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K073069Modification to Avea VentilatorViasys Respiratory Care, Inc.20083Class I
+3K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+3K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc.200539—
+3K040574Galileo GoldHamilton Medical, Inc.200453—
+3K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB2004751
+3K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+3K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+3K031656Bipap Harmony Ventilatory Support SystemRespironics, Inc.200352—
+4K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+4K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+4K183226Care Orchestrator EssenceRespironics, Inc.20190—
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112754IVENT101Versamed Medical Systems, Ltd.20129—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+4K103395Performax Total Face MaskRespironics, Inc.20110—
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+4K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+4K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+4K061090Galileo Gold AsvHamilton Medical AG200636—
+4K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+4K052863Raphael ColorHamilton Medical AG200613
+4K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+4K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+4K050759Bipap AutoRespironics, Inc.2005371
+4K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+4K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+4K032834Bipap Pro 2 BI-Level SystemRespironics, Inc.200440—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K242931HFT750UMekics Co., Ltd.20250—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+5K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+5K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+5K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+5K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K112914Vpap TXResmed, Ltd.20110—
+5K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+5K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+5K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+5K102775Hamilton-C2Hamilton Medical AG201114—
+5K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+5K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+5K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+5K072926Helontix VentLinde Gas Therapeutics20080—
+5K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+5K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+5K080181Modification to Galileo GoldHamilton Medical AG200821—
+5K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+5K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+5K070513Hamilton-G5Hamilton Medical AG2007261
+5K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+5K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+5K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+5K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+5K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—