510(k) Report

Devices descending from K990949

16 later devices reach Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081837Avea VentilatorCardinal Health 207, Inc.200813—
+1K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc.20051—
+2K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+2K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+2K072582Provox Micron HmeAtos Medical AB20080—
+3K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+3K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+6K233452Vivo 45 LSBreas Medical AB202501