# K083119: Portex Tracheal Tube, Sizes 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

- Pathway: 510(k) (Abbreviated)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jun 26, 2009 after 247 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: 3 generations back to K961837 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
4 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 4.

## Indications for use
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.

Source page: https://510kreport.com/device/K083119
Methodology: https://510kreport.com/methodology