# K955564: Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jun 28, 1996 after 205 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: 1 generation back to K934465 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites 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)
- K934465: Dic Tracheostomy Tube and Portex Blue Line, Smiths Industries Medical Systems, Inc. (1994) Summary page 2.
- (no number) Safetyflex Tracheotomy Set: named in the summary without a submission number
- (no number) Tracheoflex Tracheotomy Set: named in the summary without a submission number

## Most influential descendants
- K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile (1997), 4 descendants of its own
- 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

## Indications for use
The Risch Ultra Tracheoflex” Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.

Source page: https://510kreport.com/device/K955564
Methodology: https://510kreport.com/methodology