# K172720: TRACOE silcosoft Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Apr 27, 2018 after 231 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- 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 K081440 (2008). 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)
- K083641: Bivona Tracheostomy Tubes, Smiths Medical Asd, Inc. (2009) Summary page 4.

## Indications for use
The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.

Source page: https://510kreport.com/device/K172720
Methodology: https://510kreport.com/methodology