510(k) Report

Devices descending from K970460

174 later devices reach Nellcor Puritan Bennett, 840 Ventilator System (Model 840) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072926Helontix VentLinde Gas Therapeutics20080—
+1K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+1K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+1K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+1K013642AVEABird Products Corp.2002133Class I
+1K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp.199855Class I
+1K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp.199884
+2K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K081837Avea VentilatorCardinal Health 207, Inc.200813—
+2K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K040574Galileo GoldHamilton Medical, Inc.200453—
+2K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+2K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+2K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+2K022679RaphaelHamilton Medical AG2003543
+2K021112Inspiration Ventilator SystemeVent Medical, Ltd.20026—
+2K022674Bird Avea VentilatorBird Products Corp.2002585
+3K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+3K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+3K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K061090Galileo Gold AsvHamilton Medical AG200636—
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K053270IVENT 201Versamed Medical Systems, Inc.200687—
+3K052863Raphael ColorHamilton Medical AG200613
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+3K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+3K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+3K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+4K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K093094Vela VentilatorCardinal Health 207, Inc.20102—
+4K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+4K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+4K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+4K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+4K081845IVENT101Versamed Medical Systems, Inc.20090—
+4K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+4K080181Modification to Galileo GoldHamilton Medical AG200821—
+4K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+4K060705Carina HomeDraeger Medical B.V.2006221
+4K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+4K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+5K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K153688Edi Catheter ENFitMaquet Critical Care AB201711
+5K160481Vivo 60Breas Medical AB201672
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+5K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I