510(k) Report

Devices descending from K003068

134 later devices reach Savina through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+1K062267Oxylog 3000Drager Medical B.V.200620Class I
+1K060705Carina HomeDraeger Medical B.V.2006221
+1K023289Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072Drager Medizintechnik GmbH200317—
+1K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc.2002102—
+2K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+2K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+2K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+2K112006Hamilton-TC1Hamilton Medical AG201213—
+2K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+2K103167Stellar 150Resmed Germany, Inc.201120—
+2K093094Vela VentilatorCardinal Health 207, Inc.20102—
+2K090468Hamilton-C2Hamilton Medical AG20090—
+2K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+2K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+2K073069Modification to Avea VentilatorViasys Respiratory Care, Inc.20083Class I
+2K040574Galileo GoldHamilton Medical, Inc.200453—
+2K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+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—
+3K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+3K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+3K153046Hamilton-MR1Hamilton Medical AG20160Class I
+3K120574Hamilton-C1Hamilton Medical AG20123—
+3K113640Stellar 150Resmed Germany, Inc.20121—
+3K120670Hamilton-T1Hamilton Medical AG201211Class I
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K112914Vpap TXResmed, Ltd.20110—
+3K101643Model LTV 1100 VentilatorCare Fusion20111—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K061090Galileo Gold AsvHamilton Medical AG200636—
+3K052863Raphael ColorHamilton Medical AG200613
+3K051550Inspiration Ventilator SystemeVent Medical, Ltd.200531
+3K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+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
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K123511S9 Vpap TXResmed, Ltd.20131—
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K122324Vpap S-aResmed, Ltd.20120—
+4K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+4K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+4K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+4K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+4K072926Helontix VentLinde Gas Therapeutics20080—
+4K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+4K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+4K080181Modification to Galileo GoldHamilton Medical AG200821—
+4K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+4K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+4K070513Hamilton-G5Hamilton Medical AG2007261
+4K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+4K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+4K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+5K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K153688Edi Catheter ENFitMaquet Critical Care AB201711
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+5K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+5K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+5K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+5K103803Hamilton-G5Hamilton Medical AG201114Class I
+5K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+5K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+5K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+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—
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+6K243765LuMon (TM) SystemSentec AG20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+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
+6K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—