510(k) Report

Devices descending from K902114

28 later devices reach Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092733PYTONArm Medical Devices, Inc.201027—
+2K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+2K150893IntelliCuffHamilton Medical AG201652
+2K122721AG GuffillHospitech Respiration, Ltd.20132—
+2K103803Hamilton-G5Hamilton Medical AG201114Class I
+2K110631Venner Tracheal Seal MonitorVenner Medical (Singapore) Pte, Ltd.20110—
+3K243562CuffGuardIdmed20250—
+3K242642CuffTrekShanghai Longmann Tech Co., Ltd.20250—
+3K220854TrachCuff Cuff ControllerAw Technologies Aps20231—
+3K221477AG100sHospitech Respiration, Ltd.20220—
+3K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC202101
+3K192611CuffixBiovo Technologies, Ltd.20200—
+3K180991AG 100sHospitech Respiration, Ltd.20181—
+3K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+3K131774Hamilton-G5Hamilton Medical AG201310Class I
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K261499TrachFlushAw Technologies Aps20260—
+4K180295Hamilton-G5Hamiton Medical AG20192—
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K123637Hamilton-C3Hamilton Medical AG20124—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K193228Hamilton-G5Hamilton Medical AG20201—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—