# K972546: Rusch Single Use Crystal Tracheostomy Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Apr 14, 1998 after 280 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 K913270 (1991). 3 ancestors in all.
2 later devices descend 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)
- K934465: Dic Tracheostomy Tube and Portex Blue Line, Smiths Industries Medical Systems, Inc. (1994) Summary page 1.
- K913270: Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube, Bivona Medical Technologies (1991) Summary page 1.
- K914088: Bivona Aire-Cuf (R) Pediatric Tracheostomy Tube, Bivona Medical Technologies (1991) Summary page 1.
- (no number) Risch (Warne Surgical Products) Crystal Tracheostomy Tube - Preamendment: named in the summary without a submission number

## Most influential descendants
- K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless (2003), 1 descendant of its own
- K133173: Rusch Tracflex Plus Pediatric Tracheostomy Tube Set (2014), 0 descendants of its own

## Indications for use
The Riasch Single Use Crystal Tracheostomy Tube Set is indicated for airway management of tracheostomized patients.

Source page: https://510kreport.com/device/K972546
Methodology: https://510kreport.com/methodology