# K972423: Rusch Tracheofix-Set

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Feb 13, 1998 after 231 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mallinckrodt (Shiley) Disposable Cannula Low Pressure Cuffed Tracheostomy Tube: named in the summary without a submission number
- (no number) Smiths Industries Medical Systems (Concord/Portex) D.I.C. Tracheostomy Tubes, Cuffed: named in the summary without a submission number
- (no number) Bivona Medical Technologies AIRE-CUF Tracheostomy Tube: named in the summary without a submission number

## Indications for use
The Ritsch TracheoFix-Set (TFS) is a single patient disposable tracheostomy Tube for airway management of tracheostomized patients.

Source page: https://510kreport.com/device/K972423
Methodology: https://510kreport.com/methodology