510(k) Report

Devices descending from K942849

212 later devices reach Capnosat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961687EVITA 4Drager, Inc.1996211—
+2K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+2K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20041Class I
+2K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20042—
+2K030624Modification to Fabius GS Anesthesia SystemDraeger Medical, Inc.200415—
+2K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+2K021573Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionPuritan-Bennett200252—
+2K013642AVEABird Products Corp.2002133Class I
+2K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option…Puritan Bennett Corp.19990Class I
+2K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp.199855Class I
+2K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp.1998174Class I
+2K970165Evita 2 DuraDrager, Inc.1997140—
+3K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+3K072926Helontix VentLinde Gas Therapeutics20080—
+3K081837Avea VentilatorCardinal Health 207, Inc.200813—
+3K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+3K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+3K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+3K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+3K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+3K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+3K040574Galileo GoldHamilton Medical, Inc.200453—
+3K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2004107—
+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
+3K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+3K022679RaphaelHamilton Medical AG2003543
+3K022674Bird Avea VentilatorBird Products Corp.2002585
+3K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc.199911—
+3K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp.199884
+4K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K133886Perseus A500Draeger Medical GmbH20142Class I
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+4K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+4K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+4K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+4K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+4K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+4K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K061090Galileo Gold AsvHamilton Medical AG200636—
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+4K052863Raphael ColorHamilton Medical AG200613
+4K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+4K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+4K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+4K042607Primus USDraeger Medical, Inc.2004102
+4K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+4K021112Inspiration Ventilator SystemeVent Medical, Ltd.20026—
+5K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+5K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+5K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+5K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+5K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+5K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+5K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+5K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K103803Hamilton-G5Hamilton Medical AG201114Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K102775Hamilton-C2Hamilton Medical AG201114—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K090468Hamilton-C2Hamilton Medical AG20090—
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+5K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892