# K122235: Rusch Tracflex Plus Tracheostomy Tube Set

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Sep 6, 2013 after 407 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: 3 generations back to K934465 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile, Rusch Intl. (1997) Summary page 1.

## Most influential descendants
- K133173: Rusch Tracflex Plus Pediatric Tracheostomy Tube Set (2014), 0 descendants of its own

## Indications for use
The Rusch TracFlex Plus Tracheostomy Tube Set is used in airway management of tracheostomized patient

Source page: https://510kreport.com/device/K122235
Methodology: https://510kreport.com/methodology