510(k) Report

Devices descending from K965132

40 later devices reach HI-LO Evac and Evac II Endotracheal Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125…Covidien20232—
+1K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd.20125—
+1K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc.20092Class I
+1K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien20096—
+1K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical2008112
+1K081086Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and…Smiths Medical Asd, Inc.20083—
+1K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd.200321—
+2K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal…Covidien, LLC20250—
+2K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…Covidien, LLC20241—
+2K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC20190—
+2K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Smiths Medical Ads, Inc.20184Class I
+2K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.20180—
+2K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien20153—
+2K141939Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Teleflexmedical, Inc.20141—
+2K120985Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp.20121—
+2K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd.20112Class I
+2K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd.20103—
+2K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd.200412—
+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—
+3K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and…Salter Labs, Inc.20200—
+3K182739Endotracheal Tube with Evacuation LumenWell Lead Medical Co., Ltd.20190—
+3K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—
+3K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+3K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp.20130Class I
+3K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd.20121—
+3K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+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—
+4K180991AG 100sHospitech Respiration, Ltd.20181—
+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—
+4K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+5K221477AG100sHospitech Respiration, Ltd.20220—
+5K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+6K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—