# K042684: Well Lead Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Instruments
- Decided: Feb 17, 2005 after 141 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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 K021764 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021764: Rusch Tracheofix Set, Cuffed and Uncuffed, Rusch Intl. (2002) Summary page 1.

## Most influential descendants
- K101721: Well Lead Tracheostomy Tube and Disposable Inner Cannula (2011), 0 descendants of its own

## Indications for use
The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Source page: https://510kreport.com/device/K042684
Methodology: https://510kreport.com/methodology