# K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Oct 10, 1997 after 366 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934465 (1994). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955564: Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile, Rusch, Inc. (1996) Summary page 2.
- K934465: Dic Tracheostomy Tube and Portex Blue Line, Smiths Industries Medical Systems, Inc. (1994) Summary page 2.

## Most influential descendants
- K122235: Rusch Tracflex Plus Tracheostomy Tube Set (2013), 1 descendant of its own
- K982128: Shikani-French Speaking Valve (1998), 1 descendant of its own
- K133173: Rusch Tracflex Plus Pediatric Tracheostomy Tube Set (2014), 0 descendants of its own
- K100995: Shikani Speaking Valve (2010), 0 descendants of its own

## Recalls of this device
- Aug 26, 2016 · Class I · Z-0044-2017: The connector may disconnect from the tracheostomy tube during use.

## Indications for use
The Rusch UltraTracheoflex®/Tracheoflex® Tracheostomy Tube Kits are intended for use in airway management of tracheostomized patients.

Source page: https://510kreport.com/device/K964056
Methodology: https://510kreport.com/methodology