510(k) Report

Devices descending from K902859

235 later devices reach Servo Ventilator 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc.200451
+1K021573Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionPuritan-Bennett200252—
+1K013642AVEABird Products Corp.2002133Class I
+1K990897Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerPuritan-Bennett Ireland, Ltd.200022
+1K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp.199855Class I
+1K974176Babylog 8000 PlusDrager, Inc.19981511
+1K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp.1998174Class I
+1K970165Evita 2 DuraDrager, Inc.1997140—
+1K961687EVITA 4Drager, Inc.1996211—
+1K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB1996178—
+2K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+2K103211Avea VentilatorCare Fusion20115Class I
+2K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB20114—
+2K100011Fisher & Paykel Healthcare Bubble Cpap SystemFisher & Paykel Healthcare, Ltd.20103—
+2K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+2K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+2K083050Evite XLDraeger Medical AG & Co. KG20082—
+2K072926Helontix VentLinde Gas Therapeutics20080—
+2K081837Avea VentilatorCardinal Health 207, Inc.200813—
+2K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+2K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+2K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+2K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+2K040574Galileo GoldHamilton Medical, Inc.200453—
+2K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2004107—
+2K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20041Class I
+2K041082Newport Nebsonic N550 Ultrasonic NebulizerNewport Medical Instruments, Inc.20040—
+2K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20042—
+2K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+2K030624Modification to Fabius GS Anesthesia SystemDraeger Medical, Inc.200415—
+2K022679RaphaelHamilton Medical AG2003543
+2K021112Inspiration Ventilator SystemeVent Medical, Ltd.20026—
+2K022674Bird Avea VentilatorBird Products Corp.2002585
+2K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+2K020357800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc.20020Class I
+2K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option…Puritan Bennett Corp.19990Class I
+2K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999134—
+2K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc.19996—
+2K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc.199911—
+2K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp.199884
+2K970839Servo Ventilator 300ASiemens Elema AB19971714
+3K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+3K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+3K221436F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd.20230—
+3K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+3K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K143700CPAP CannulaideSalter Labs20150—
+3K133886Perseus A500Draeger Medical GmbH20142Class I
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+3K131502Seattle - PapSeattle Childrens Hospital20130Class I
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB20123Class I
+3K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+3K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+3K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+3K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+3K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+3K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+3K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+3K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K061090Galileo Gold AsvHamilton Medical AG200636—
+3K060705Carina HomeDraeger Medical B.V.2006221
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K053270IVENT 201Versamed Medical Systems, Inc.200687—
+3K052863Raphael ColorHamilton Medical AG200613
+3K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+3K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+3K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+3K042607Primus USDraeger Medical, Inc.2004102
+3K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+3K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.200414—
+3K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+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—
+3K993449Bird V.I.P. Gold/SterlingBird Products Corp.19991342
+4K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+4K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+4K222897Enlight 2100Timpel S.A.20232—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—