510(k) Report

Devices descending from K000706

158 later devices reach Datex-Ohmeda Aestiva/5 with 7100 Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+1K081447Fourth Gas Module with CO2 for Primus US ApolloDraeger Medical AG & Co. KG200801
+1K032803Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda200439—
+1K013642AVEABird Products Corp.2002133Class I
+2K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+2K081837Avea VentilatorCardinal Health 207, Inc.200813—
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K042154GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc.2004363
+2K040743Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc.200438—
+2K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+2K022674Bird Avea VentilatorBird Products Corp.2002585
+3K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+3K090892GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy200901
+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
+3K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda200733—
+3K061609GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2006341
+3K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+3K053270IVENT 201Versamed Medical Systems, Inc.200687—
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K050676GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)Datex-Ohmeda, Inc.200513
+3K050626GE Datex-Ohmeda Aespire 7900 Anesthesia SystemDatex-Ohmeda, Inc.200541
+3K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+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
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K101643Model LTV 1100 VentilatorCare Fusion20111—
+4K093094Vela VentilatorCardinal Health 207, Inc.20102—
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K092864Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C20103—
+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
+4K072926Helontix VentLinde Gas Therapeutics20080—
+4K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.2008304
+4K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division2008112
+4K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+4K060705Carina HomeDraeger Medical B.V.2006221
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+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—
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K122445Aespire 7900, Aespire ViewDatex-Ohmeda20122Class I
+5K120075AM-6000 Anesthesia MachineAdvanced Instrumentations, Inc.20120—
+5K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+5K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+5K103211Avea VentilatorCare Fusion20115Class I
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K103167Stellar 150Resmed Germany, Inc.201120—
+5K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc.20119Class I
+5K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+5K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2009192
+5K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+5K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+5K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+6K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K161420Moves SLCThornhill Research, Inc.20170—
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—