510(k) Report

Devices descending from K912124

37 later devices reach Tracheostomy Tube and Cuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+1K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd.200321—
+1K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd.200382
+1K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH19963—
+1K960429Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner CannulaSmiths Industries Medical Systems, Inc.199632—
+2K233713Pilling Tracheostomy TubesTeleflex Medical20240—
+2K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Smiths Medical Ads, Inc.20184Class I
+2K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+2K100283Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…Cook, Inc.20100—
+2K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+2K081086Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and…Smiths Medical Asd, Inc.20083—
+2K050166Portex Emergency Cricothyroidotomy KitSmiths Medical20050—
+2K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+2K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd.200412—
+2K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc.200317
+2K980466Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Sims Portex, Inc.1998311
+3K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…Vitaltec Corporation20251—
+3K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…Smiths Medical Asd, Inc.20210—
+3K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—
+3K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+3K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+3K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd.20121—
+3K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc.20092Class I
+3K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments20085—
+3K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd.20056—
+4K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…Vitaltec Corporation20260—
+4K242495LMA Fastrach ETT SUTeleflex Medical20250—
+4K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+4K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—
+4K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.20180—
+4K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd.20171—
+4K140228Disposable Tracheal TubeSuzhou Weikang Medical Apparatus Co., Ltd.20141—
+4K141939Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Teleflexmedical, Inc.20141—
+4K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+5K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—
+5K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+6K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—