# K041311: Tiger Endotracheal Tubes (Various Models and Sizes)

- Pathway: 510(k) (Abbreviated)
- Applicant: Tiger Medical Products, Ltd.
- Decided: Mar 18, 2005 after 305 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: 1 generation back to K892432 (1989). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892432: Kendall Curity Endotracheal Tubes, The Kendal Co. (1989) Summary page 1.
- K931164: Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EY, Rusch, Inc. (1993) Summary page 1.
- K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye, Rusch, Inc. (1993) Summary page 1.
- K931165: Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur Eye, Rusch, Inc. (1993) Summary page 1.
- K931166: Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EY, Rusch, Inc. (1993) Summary page 1.

## Most influential descendants
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## Indications for use
The indication for use for all the product variants is grouped into three different sections: (a) Uncuffed, oral/nasal and Cuffed, oral/nasal: The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management. (b) Uncuffed, nasal only and Cuffed, nasal only: The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face. (c) Uncuffed, oral only and Cuffed, oral only: The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.

Source page: https://510kreport.com/device/K041311
Methodology: https://510kreport.com/methodology