510(k) Report

Devices descending from K010093

95 later devices reach Non-Invasive Ventilation Niv Option, Model 84 14 474 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+1K083050Evite XLDraeger Medical AG & Co. KG20082—
+1K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+1K040574Galileo GoldHamilton Medical, Inc.200453—
+1K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+1K023289Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072Drager Medizintechnik GmbH200317—
+2K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+2K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+2K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+2K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+2K121225Hamilton-C2Hamilton Medical AG20128Class I
+2K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+2K102775Hamilton-C2Hamilton Medical AG201114—
+2K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+2K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+2K090468Hamilton-C2Hamilton Medical AG20090—
+2K072926Helontix VentLinde Gas Therapeutics20080—
+2K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K080181Modification to Galileo GoldHamilton Medical AG200821—
+2K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+2K070513Hamilton-G5Hamilton Medical AG2007261
+2K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K061090Galileo Gold AsvHamilton Medical AG200636—
+2K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+2K052863Raphael ColorHamilton Medical AG200613
+2K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+3K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+3K222897Enlight 2100Timpel S.A.20232—
+3K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+3K153688Edi Catheter ENFitMaquet Critical Care AB201711
+3K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+3K123637Hamilton-C3Hamilton Medical AG20124—
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+3K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+3K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+3K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+3K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+3K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+4K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+4K243765LuMon (TM) SystemSentec AG20250—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+4K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+4K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+4K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+4K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+4K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+4K103211Avea VentilatorCare Fusion20115Class I
+4K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+4K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K170872Aisys CS2Datex-Ohmeda, Inc.201704
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+5K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+6K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+7K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+7K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+8K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—