510(k) Report

Devices descending from K001646

112 later devices reach Puritan-Bennett 840 Ventilator System with Neomode Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+1K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+1K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+1K040574Galileo GoldHamilton Medical, Inc.200453—
+1K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc.2002102—
+2K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+2K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+2K103211Avea VentilatorCare Fusion20115Class I
+2K093094Vela VentilatorCardinal Health 207, Inc.20102—
+2K073069Modification to Avea VentilatorViasys Respiratory Care, Inc.20083Class I
+2K061090Galileo Gold AsvHamilton Medical AG200636—
+2K052863Raphael ColorHamilton Medical AG200613
+2K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+2K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB2004751
+2K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+2K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.20044—
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+3K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+3K070513Hamilton-G5Hamilton Medical AG2007261
+3K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+3K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+3K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+3K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+3K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+4K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+4K222897Enlight 2100Timpel S.A.20232—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+4K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+4K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K103803Hamilton-G5Hamilton Medical AG201114Class I
+4K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+4K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+4K090468Hamilton-C2Hamilton Medical AG20090—
+4K072926Helontix VentLinde Gas Therapeutics20080—
+4K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+4K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+4K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+5K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+5K243765LuMon (TM) SystemSentec AG20250—
+5K233452Vivo 45 LSBreas Medical AB202501
+5K153688Edi Catheter ENFitMaquet Critical Care AB201711
+5K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+5K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+5K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+5K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+5K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+5K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K180295Hamilton-G5Hamiton Medical AG20192—
+6K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+6K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+6K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+6K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+6K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+6K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+6K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+7K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+7K193228Hamilton-G5Hamilton Medical AG20201—