510(k) Report

Devices descending from K022674

58 later devices reach Bird Avea Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+1K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+1K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+2K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+2K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+2K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+2K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+2K133868Astral VentilatorResmed, Ltd.2014102
+2K131774Hamilton-G5Hamilton Medical AG201310Class I
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+2K101643Model LTV 1100 VentilatorCare Fusion20111—
+2K093094Vela VentilatorCardinal Health 207, Inc.20102—
+2K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+2K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+2K081845IVENT101Versamed Medical Systems, Inc.20090—
+2K072926Helontix VentLinde Gas Therapeutics20080—
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+3K180295Hamilton-G5Hamiton Medical AG20192—
+3K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K161450Hamilton-C3Hamilton Medical AG201732
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K153688Edi Catheter ENFitMaquet Critical Care AB201711
+3K160481Vivo 60Breas Medical AB201672
+3K153046Hamilton-MR1Hamilton Medical AG20160Class I
+3K152068Astral 100/150Resmed, Ltd.20161Class I
+3K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+3K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+3K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+3K103211Avea VentilatorCare Fusion20115Class I
+3K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+4K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K201306Hamilton-C3Hamilton Medical AG20210Class I
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K201658Hamilton-C6Hamilton Medical AG20201Class I
+4K193228Hamilton-G5Hamilton Medical AG20201—
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+4K172875Astral 100/150Resmed, Ltd.20180Class I
+4K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+4K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+5K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K233452Vivo 45 LSBreas Medical AB202501
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+5K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+5K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K122438Hamilton-MR1Hamilton Medical AG201311
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I