# K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Mar 28, 2003 after 123 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913270 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972546: Rusch Single Use Crystal Tracheostomy Tube Set, Rusch Intl. (1998) Summary page 1.

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

## Recalls of this device
- Apr 4, 2011 · Not classified · Z-2695-2011: Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
- Apr 4, 2011 · Not classified · Z-2697-2011: Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.

## Indications for use
The Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

Source page: https://510kreport.com/device/K023918
Methodology: https://510kreport.com/methodology