510(k) Report

Devices descending from K960429

32 later devices reach Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc.200317
+1K980466Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Sims Portex, Inc.1998311
+2K050166Portex Emergency Cricothyroidotomy KitSmiths Medical20050—
+2K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+2K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd.200321—
+2K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd.200382
+3K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+3K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Smiths Medical Ads, Inc.20184Class I
+3K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+3K100283Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…Cook, Inc.20100—
+3K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+3K081086Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and…Smiths Medical Asd, Inc.20083—
+3K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd.200412—
+4K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…Vitaltec Corporation20251—
+4K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…Smiths Medical Asd, Inc.20210—
+4K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—
+4K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+4K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—
+4K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd.20121—
+4K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc.20092Class I
+4K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments20085—
+4K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd.20056—
+5K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…Vitaltec Corporation20260—
+5K242495LMA Fastrach ETT SUTeleflex Medical20250—
+5K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.20180—
+5K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd.20171—
+5K140228Disposable Tracheal TubeSuzhou Weikang Medical Apparatus Co., Ltd.20141—
+5K141939Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Teleflexmedical, Inc.20141—
+5K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+6K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—
+6K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+7K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—