# K073383: Well Lead Reinforced Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Instruments
- Decided: Jul 10, 2008 after 220 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: 5 generations back to K903730 (1990). 18 ancestors in all.
5 later devices descend from it; 3 cite it directly.
4 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed), Portex, Ltd. (2004) Summary page 2.
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 2.

## Most influential descendants
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K140228: Disposable Tracheal Tube (2014), 1 descendant of its own
- K111406: Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal Tube Without Cuff (Oral/Nasal) (2012), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own
- K170234: Endotracheal tube; Reinforced Endotracheal tube (2018), 0 descendants of its own

## Indications for use
The Well Lead Reinforced Endotracheal Tubes 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/K073383
Methodology: https://510kreport.com/methodology