510(k) Report

Devices descending from K981072

145 later devices reach Esprit Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+1K102054V200 VentilatorRespironics California, Inc.20102—
+1K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+1K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc.20076—
+1K071212Esprit Ventilator Speaking Mode Option, Model V1000Respironics California, Inc.20070—
+1K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+1K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+1K034032PLV Continuum Ventilator, Model P2000Respironics California, Inc.20041—
+1K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+1K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc.2003292
+2K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+2K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+2K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+2K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+2K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+2K110795V200 Intelli-Trak OptionRespironics California, Inc.20110—
+2K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+2K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K081845IVENT101Versamed Medical Systems, Inc.20090—
+2K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+2K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K053270IVENT 201Versamed Medical Systems, Inc.200687—
+2K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+3K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+3K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+3K183226Care Orchestrator EssenceRespironics, Inc.20190—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+3K112754IVENT101Versamed Medical Systems, Ltd.20129—
+3K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+3K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+3K093261MOVESThornhill Research, Inc.20107Class I
+3K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+3K060705Carina HomeDraeger Medical B.V.2006221
+4K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+4K242931HFT750UMekics Co., Ltd.20250—
+4K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+4K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+4K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+4K133868Astral VentilatorResmed, Ltd.2014102
+4K140049Moves SLCThornhill Research, Inc.20141—
+4K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+4K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+4K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+4K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+5K160481Vivo 60Breas Medical AB201672
+5K152068Astral 100/150Resmed, Ltd.20161Class I
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+5K112914Vpap TXResmed, Ltd.20110—
+5K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+5K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+5K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+5K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+6K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+6K122438Hamilton-MR1Hamilton Medical AG201311
+6K131774Hamilton-G5Hamilton Medical AG201310Class I
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K122324Vpap S-aResmed, Ltd.20120—
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K103803Hamilton-G5Hamilton Medical AG201114Class I
+6K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—