510(k) Report

Devices descending from K081837

13 later devices reach Avea Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+1K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+2K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+2K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+3K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+5K233452Vivo 45 LSBreas Medical AB202501