# K101721: Well Lead Tracheostomy Tube and Disposable Inner Cannula

- Pathway: 510(k) (Special)
- Applicant: Regulatory and Marketing Services, Inc.
- Decided: Mar 24, 2011 after 279 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: 2 generations back to K021764 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042684: Well Lead Tracheostomy Tube, Well Lead Medical Instruments (2005) Summary page 2.

## Indications for use
The Well Lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomnotized patients.

Source page: https://510kreport.com/device/K101721
Methodology: https://510kreport.com/methodology