# K021764: Rusch Tracheofix Set, Cuffed and Uncuffed

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Jul 23, 2002 after 55 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 DCT Tracheostomy Tube Cuffed and Uncuffed: named in the summary without a submission number
- (no number) Smiths Industries (SIMS Concord-Portex) D.I.C. (Disposable Inner Cannula) Tracheostomy Tubes, Cuffed and Uncuffed: named in the summary without a submission number
- (no number) Bivona Medical Technologies AIRE-CUP Tracheostomy Tube: named in the summary without a submission number
- (no number) Rusch Crystal Tracheostomy Tube: named in the summary without a submission number
- (no number) Rusch TracheoFlex Sets: named in the summary without a submission number

## Most influential descendants
- K042684: Well Lead Tracheostomy Tube (2005), 1 descendant of its own
- K101721: Well Lead Tracheostomy Tube and Disposable Inner Cannula (2011), 0 descendants of its own

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

Source page: https://510kreport.com/device/K021764
Methodology: https://510kreport.com/methodology