510(k) Report

Devices descending from K112754

9 later devices reach IVENT101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+2K160481Vivo 60Breas Medical AB201672
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K233452Vivo 45 LSBreas Medical AB202501
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—