510(k) Report

Devices descending from K060647

29 later devices reach LTV 1200 Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+1K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+1K133868Astral VentilatorResmed, Ltd.2014102
+1K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+1K101643Model LTV 1100 VentilatorCare Fusion20111—
+1K093094Vela VentilatorCardinal Health 207, Inc.20102—
+1K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+1K081845IVENT101Versamed Medical Systems, Inc.20090—
+1K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+2K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K160481Vivo 60Breas Medical AB201672
+2K152068Astral 100/150Resmed, Ltd.20161Class I
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+2K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+2K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K233486731 Series VentilatorZOLL Medical Corporation20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K172875Astral 100/150Resmed, Ltd.20180Class I
+3K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K233452Vivo 45 LSBreas Medical AB202501
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K122438Hamilton-MR1Hamilton Medical AG201311
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I