510(k) Report

Devices descending from K030570

21 later devices reach Blue Line Ultra Suctionaid Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Smiths Medical Ads, Inc.20184Class I
+1K081086Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and…Smiths Medical Asd, Inc.20083—
+1K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd.200412—
+2K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…Vitaltec Corporation20251—
+2K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…Smiths Medical Asd, Inc.20210—
+2K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—
+2K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd.20121—
+2K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc.20092Class I
+2K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+2K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments20085—
+2K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd.20056—
+3K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…Vitaltec Corporation20260—
+3K242495LMA Fastrach ETT SUTeleflex Medical20250—
+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—
+3K141939Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Teleflexmedical, Inc.20141—
+3K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+4K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—
+4K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+5K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—