# K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Jan 26, 2004 after 201 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: 4 generations back to K903730 (1990). 12 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962389: Euromedical Reinforced Endotracheal Tube, Unomedical Sdn Bhd (1996) Summary page 1.
- K962175: Portex Adjustable Flange Tracheostomy Tube, Smiths Industries Medical Systems, Inc. (1997) Summary page 1.
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube, Portex, Ltd. (2003). Cleared while this submission was under review Summary page 1.
- (no number) Mallinckrodt Tracheal tube Cuffed/Uncuffed: named in the summary without a submission number
- (no number) Portex Blue Line Tracheal tube PVC Cuffed (100/199): named in the summary without a submission number

## Most influential descendants
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K130304: Lma Family of Airways (2014), 4 descendants of its own
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own

## Indications for use
The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

Source page: https://510kreport.com/device/K032112
Methodology: https://510kreport.com/methodology