510(k) Report

Devices descending from K984056

40 later devices reach LTV 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+1K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+1K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+1K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+1K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+1K034032PLV Continuum Ventilator, Model P2000Respironics California, Inc.20041—
+1K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc.2003292
+2K183226Care Orchestrator EssenceRespironics, Inc.20190—
+2K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+2K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+2K112754IVENT101Versamed Medical Systems, Ltd.20129—
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+2K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+2K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+2K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+2K081845IVENT101Versamed Medical Systems, Inc.20090—
+3K233486731 Series VentilatorZOLL Medical Corporation20240—
+3K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+3K133868Astral VentilatorResmed, Ltd.2014102
+3K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+3K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+3K122715Stellar 150Resmed Germany, Inc.20130Class I
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+3K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+3K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K160481Vivo 60Breas Medical AB201672
+4K152068Astral 100/150Resmed, Ltd.20161Class I
+5K233452Vivo 45 LSBreas Medical AB202501
+5K172875Astral 100/150Resmed, Ltd.20180Class I