510(k) Report

Devices descending from K902506

251 later devices reach 7200AE Microprocessor Ventilator W/Enhanced Hard. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K132017HC550 Respiratory Humidifier, Adult Ventilator CircuitFisher & Paykel Healthcare, Ltd.20140—
+5K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc.20141Class I
+5K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+5K131774Hamilton-G5Hamilton Medical AG201310Class I
+5K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd.201325—
+5K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd.20126—
+5K121225Hamilton-C2Hamilton Medical AG20128Class I
+5K110019Respiratory HumidiferFisher & Paykel Healthcare, Ltd.20122—
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K103803Hamilton-G5Hamilton Medical AG201114Class I
+5K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc.20102—
+5K100554Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441Fisher & Paykel Healthcare, Ltd.20104—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd.201030—
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+5K060705Carina HomeDraeger Medical B.V.2006221
+6K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.20260—
+6K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+6K243765LuMon (TM) SystemSentec AG20250—
+6K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+6K233707HFT150Invent Medical Corporation20240—
+6K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+6K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+6K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K180295Hamilton-G5Hamiton Medical AG20192—
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+6K180474TNI softFlow 50Tni Medical AG20180—
+6K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K153688Edi Catheter ENFitMaquet Critical Care AB201711
+6K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.20170Class I
+6K160481Vivo 60Breas Medical AB201672
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+6K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+6K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.20150—
+6K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+6K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+6K140049Moves SLCThornhill Research, Inc.20141—
+6K131957MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…Fisher & Paykel Healthcare, Ltd.20133—
+6K123637Hamilton-C3Hamilton Medical AG20124—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K103211Avea VentilatorCare Fusion20115Class I
+6K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+6K103167Stellar 150Resmed Germany, Inc.201120—
+6K103316FlowrestVapotherm, Inc.20113—
+6K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+6K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+7K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+7K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+7K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+7K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+7K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+7K210384Carescape R860Datex-Ohmeda, Inc.20210—
+7K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+7K193228Hamilton-G5Hamilton Medical AG20201—
+7K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+7K191010Palladium High Flow Therapy SystemVapotherm, Inc.20192—
+7K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+7K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K161420Moves SLCThornhill Research, Inc.20170—
+7K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+7K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitFisher & Paykel Healthcare, Ltd.20151—
+7K141940Conchasmart ColumnTeleflex, Inc.20140—
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K113640Stellar 150Resmed Germany, Inc.20121—
+7K113288Vpap ST-aResmed, Ltd.20127—