510(k) Report

Devices descending from K181166

5 later devices reach Trilogy Evo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+1K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+1K240807VM-2000Ventis Medical, Inc.20240—
+1K193586Vivo 45 LSBreas Medical AB20212Class I
+2K233452Vivo 45 LSBreas Medical AB202501