TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT— 510(k) K091761

Clearance details

Applicant

Teleflexmedical, Inc.

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

2009-06-16

Decision date

2009-10-29

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Durham, NC, US

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• K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)2025-10-06
• K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced2025-09-25
• K243579 — AeroJet Ventilation Catheter2025-08-13

• K232469 — Rüsch Latex Gold Foley Catheter2024-08-01
• K212077 — Teleflex Rusch SoftSimplastic Foley Catheters2023-07-27
• K192324 — Sheridan Spiral-Flex Endotracheal Tubes2019-12-06
• K182847 — Hudson RCI Voldyne Volumetric Exerciser2019-07-01
• K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1956-2019 — Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.Class I·Terminated·Centurion Medical Products Corporation·20190607
• Z-0950-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0951-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0952-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0953-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0954-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0955-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0956-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0957-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0958-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0959-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0960-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0961-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0962-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106
• Z-0963-2014 — ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.Class I·Terminated·Teleflex Medical·20140106

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091761.