# K013321: Silicone Tracheal T-Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Technical Products, Inc.
- Decided: Jun 4, 2002 after 242 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own

## Indications for use
1. As a stent to aid in the rehabilitation of tracheal stenosis 2. As a stent to temporarily aid in laryngotracheal injuries 3. To support a Reconstituted Trachea 4. As a stent to provide an airway for a cervical trachea that cannot be repaired

Source page: https://510kreport.com/device/K013321
Methodology: https://510kreport.com/methodology