# K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Oct 25, 2005 after 132 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 K922665 (1993). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922665: Bivona Hyperflex Tracheostomy Tube, Bivona Medical Technologies (1993) Summary page 3.

## 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
- K203362: TRACOE vario (2021), 0 descendants of its own

## Indications for use
TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management to those patients with unusual anatomy or thick neck patients.

Source page: https://510kreport.com/device/K051587
Methodology: https://510kreport.com/methodology