510(k) Report

Devices descending from K970839

171 later devices reach Servo Ventilator 300A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060705Carina HomeDraeger Medical B.V.2006221
+1K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+1K051262Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc.200501
+1K040574Galileo GoldHamilton Medical, Inc.200453—
+1K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc.200451
+1K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB2004751
+1K993449Bird V.I.P. Gold/SterlingBird Products Corp.19991342
+1K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999134—
+2K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+2K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB20114—
+2K103167Stellar 150Resmed Germany, Inc.201120—
+2K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+2K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+2K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+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
+2K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB200473Class I
+2K013642AVEABird Products Corp.2002133Class I
+3K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+3K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+3K222897Enlight 2100Timpel S.A.20232—
+3K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+3K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K113640Stellar 150Resmed Germany, Inc.20121—
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+3K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB20123Class I
+3K112914Vpap TXResmed, Ltd.20110—
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K072926Helontix VentLinde Gas Therapeutics20080—
+3K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+3K081837Avea VentilatorCardinal Health 207, Inc.200813—
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K070513Hamilton-G5Hamilton Medical AG2007261
+3K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+3K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+3K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K022674Bird Avea VentilatorBird Products Corp.2002585
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+4K243765LuMon (TM) SystemSentec AG20250—
+4K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+4K153688Edi Catheter ENFitMaquet Critical Care AB201711
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB20142Class I
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K123511S9 Vpap TXResmed, Ltd.20131—
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K122324Vpap S-aResmed, Ltd.20120—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+4K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+4K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+4K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+4K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+4K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+5K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K210384Carescape R860Datex-Ohmeda, Inc.20210—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+5K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB20171—
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I