510(k) Report

Devices descending from K092135

10 later devices reach Modification to Ivent 101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112754IVENT101Versamed Medical Systems, Ltd.20129—
+2K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+3K160481Vivo 60Breas Medical AB201672
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K233452Vivo 45 LSBreas Medical AB202501
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—