# K203362: TRACOE vario

- Pathway: 510(k) (Traditional)
- Applicant: Tracoe Medical GmbH
- Decided: Aug 5, 2021 after 262 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 K922665 (1993). 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)
- K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470, Tracoe Medical GmbH (2005) Summary page 4.

## Indications for use
TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.

Source page: https://510kreport.com/device/K203362
Methodology: https://510kreport.com/methodology