510(k) Report

Devices descending from K962175

23 later devices reach Portex Adjustable Flange Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+1K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd.200412—
+1K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited200310—
+2K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd.20121—
+2K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments20085—
+2K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd.20056—
+2K041044Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc.20042—
+2K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+2K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd.20046—
+3K242495LMA Fastrach ETT SUTeleflex Medical20250—
+3K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+3K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.20180—
+3K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd.20171—
+3K140228Disposable Tracheal TubeSuzhou Weikang Medical Apparatus Co., Ltd.20141—
+3K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+3K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+3K072148Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerCook, Inc.20071—
+4K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+4K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—
+4K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—
+4K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+4K093469Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…Cook, Inc.2010017
+5K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—