# K100480: Rota-Trach Tracheostomy Tube Model Rota-Trach

- Pathway: 510(k) (Traditional)
- Applicant: Vitaltec Corporation
- Decided: Jun 11, 2010 after 113 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 K862267 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031553: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes, Arcadia Medical Corporation (2003) Summary page 1.

## Indications for use
Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.

Source page: https://510kreport.com/device/K100480
Methodology: https://510kreport.com/methodology