510(k) Report

Devices descending from K973646

125 later devices reach Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161718MaxBlend 2, MaxBlend LiteMaxtec, LLC20162—
+1K113232Maxmixing BlockMaxtec, Inc.20120—
+1K020746Bird Tbird Vela VentilatorBird Products Corp.2002120—
+2K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+2K231895Maxtec MaxBlend2+pMaxtec, LLC20230—
+2K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+2K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K053270IVENT 201Versamed Medical Systems, Inc.200687—
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+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
+4K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+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—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K103167Stellar 150Resmed Germany, Inc.201120—
+5K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+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—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K161420Moves SLCThornhill Research, Inc.20170—
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+6K122715Stellar 150Resmed Germany, Inc.20130Class I
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K113288Vpap ST-aResmed, Ltd.20127—
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K112914Vpap TXResmed, Ltd.20110—
+6K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+6K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+6K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+6K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+7K160481Vivo 60Breas Medical AB201672
+7K153061Juno VPAP ST-AResmed, Ltd.20163—
+7K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K131774Hamilton-G5Hamilton Medical AG201310Class I
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K122324Vpap S-aResmed, Ltd.20120—
+7K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+7K103803Hamilton-G5Hamilton Medical AG201114Class I
+7K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+7K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+7K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K180295Hamilton-G5Hamiton Medical AG20192—
+8K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+8K153688Edi Catheter ENFitMaquet Critical Care AB201711
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+8K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+8K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+8K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+8K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+8K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I