510(k) Report

Devices descending from K970165

140 later devices reach Evita 2 Dura through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K180295Hamilton-G5Hamiton Medical AG20192—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+6K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K103211Avea VentilatorCare Fusion20115Class I
+6K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K210384Carescape R860Datex-Ohmeda, Inc.20210—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K193228Hamilton-G5Hamilton Medical AG20201—
+7K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+7K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+7K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+7K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+8K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+8K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+9K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+9K152664TAV SystemNew Aera, Inc.20160—
+9K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+10K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I