510(k) Report

Devices descending from K961687

211 later devices reach EVITA 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+4K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+4K060705Carina HomeDraeger Medical B.V.2006221
+4K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+4K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+4K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+5K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+5K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+5K243765LuMon (TM) SystemSentec AG20250—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+5K153688Edi Catheter ENFitMaquet Critical Care AB201711
+5K160481Vivo 60Breas Medical AB201672
+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—
+5K112754IVENT101Versamed Medical Systems, Ltd.20129—
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+5K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+5K103211Avea VentilatorCare Fusion20115Class 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—
+5K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+5K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+5K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+5K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+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—
+5K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+6K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+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—
+6K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+6K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+6K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+6K122715Stellar 150Resmed Germany, Inc.20130Class I
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+6K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+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—
+6K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+6K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+7K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+7K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+7K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+7K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+7K153061Juno VPAP ST-AResmed, Ltd.20163—
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K122324Vpap S-aResmed, Ltd.20120—
+7K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+7K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+7K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—