510(k) Report

Devices descending from K962517

196 later devices reach Model 7700 Quantum Pressure Support Ventilator PSV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+6K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+6K222897Enlight 2100Timpel S.A.20232—
+6K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+6K153688Edi Catheter ENFitMaquet Critical Care AB201711
+6K160481Vivo 60Breas Medical AB201672
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+6K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+6K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+6K121225Hamilton-C2Hamilton Medical AG20128Class I
+6K122324Vpap S-aResmed, Ltd.20120—
+6K112006Hamilton-TC1Hamilton Medical AG201213—
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K103803Hamilton-G5Hamilton Medical AG201114Class I
+6K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+6K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+6K090468Hamilton-C2Hamilton Medical AG20090—
+6K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+6K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+6K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+7K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+7K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+7K243765LuMon (TM) SystemSentec AG20250—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K212263Luna G3 BPAP System3B Medical, Inc.20220—
+7K210384Carescape R860Datex-Ohmeda, Inc.20210—
+7K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+7K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+7K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K131774Hamilton-G5Hamilton Medical AG201310Class I
+7K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+7K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+7K123637Hamilton-C3Hamilton Medical AG20124—
+7K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+7K120574Hamilton-C1Hamilton Medical AG20123—
+7K120670Hamilton-T1Hamilton Medical AG201211Class I
+7K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+7K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+7K103211Avea VentilatorCare Fusion20115Class I
+7K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+7K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+8K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+8K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+8K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+8K180295Hamilton-G5Hamiton Medical AG20192—
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+8K161450Hamilton-C3Hamilton Medical AG201732
+8K153046Hamilton-MR1Hamilton Medical AG20160Class I
+8K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+8K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+8K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+8K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+8K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+8K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+8K122769Remstar SERespironics, Inc.20123Class I
+9K233486731 Series VentilatorZOLL Medical Corporation20240—
+9K201306Hamilton-C3Hamilton Medical AG20210Class I
+9K201658Hamilton-C6Hamilton Medical AG20201Class I
+9K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+9K193228Hamilton-G5Hamilton Medical AG20201—
+9K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+9K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+9K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+9K130077Remstar SERespironics, Inc.20132Class I
+10K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+10K251770SleepRes PAP SystemSleepres, Inc.20250—
+10K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+10K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+10K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+10K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+11K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—