# K100283: Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes C-VT, C-Vtic

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Apr 23, 2010 after 81 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: 4 generations back to K903730 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula, Portex, Ltd. (2003) Summary page 2.

## Indications for use
The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.

Source page: https://510kreport.com/device/K100283
Methodology: https://510kreport.com/methodology