510(k) Report

Devices descending from K092847

11 later devices reach 840 Ventilator System with Expanded Neomode Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+1K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+2K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+2K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+3K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+4K233452Vivo 45 LSBreas Medical AB202501