510(k) Report

Devices descending from K950484

162 later devices reach Tbird VS Ventilator and Tbird Avs Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K122324Vpap S-aResmed, Ltd.20120—
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+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—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+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—
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K152664TAV SystemNew Aera, Inc.20160—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K131774Hamilton-G5Hamilton Medical AG201310Class I
+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—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+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
+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
+8K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+8K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+8K103211Avea VentilatorCare Fusion20115Class I
+9K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+9K210384Carescape R860Datex-Ohmeda, Inc.20210—
+9K193228Hamilton-G5Hamilton Medical AG20201—
+9K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+9K170872Aisys CS2Datex-Ohmeda, Inc.201704
+9K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+9K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+9K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+9K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+10K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+10K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+10K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+10K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+10K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+10K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+11K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+11K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+11K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+11K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+12K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—