# K141939: Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Nov 24, 2014 after 130 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903730 (1990). 13 ancestors in all.
1 later device descends 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)
- K091761: Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port, Teleflexmedical, Inc. (2009) Summary page 5.

## Most influential descendants
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## 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/K141939
Methodology: https://510kreport.com/methodology