# K133173: Rusch Tracflex Plus Pediatric Tracheostomy Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: May 23, 2014 after 218 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: 4 generations back to K934465 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless, Rusch Intl. (2003) Summary page 2.
- K122235: Rusch Tracflex Plus Tracheostomy Tube Set, Teleflexmedical, Inc. (2013) Summary page 2.

## Indications for use
The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients. Patient Population: Pediatric Patients per below: Pediatric Subgroup Approximate Age Range Neonate/Newborn Birth to 28 days Infant 29 days to < 2 years Child 2 years to <12 years Adolescent 12 years to < 18 years Transitional Adolescent A 18 years to <21 years Environment of use: Home, Hospital and Sub-acute Institutions

Source page: https://510kreport.com/device/K133173
Methodology: https://510kreport.com/methodology