# K091761: Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port

- Pathway: 510(k) (Abbreviated)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 29, 2009 after 135 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 15 (15 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K903730 (1990). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822082: Sheridan/HVT,CF, Uncuffed, Sheridan Catheter Corp. (1982) Summary page 2.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 2.
- K081086: Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0, Smiths Medical Asd, Inc. (2008) Summary page 2.

## Most influential descendants
- K141939: Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet (2014), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## Recalls of this device
- Jun 7, 2019 · Class I · Z-1956-2019: Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
- Jan 6, 2014 · Class I · Z-0950-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0953-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0954-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0957-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0958-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0959-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0961-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0963-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0955-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0956-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0960-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0962-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0951-2014: The tracheal tube can kink during patient use.
- Jan 6, 2014 · Class I · Z-0952-2014: The tracheal tube can kink during patient use.

## Indications for use
The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

Source page: https://510kreport.com/device/K091761
Methodology: https://510kreport.com/methodology