# K955495: Rusch Reinforced Trachael Tube Cuffed, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jun 27, 1996 after 209 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- 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 K830352 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844296: Tracheal Tube, Reinforced, Cuffed, Sheridan Catheter Corp. (1984) Summary page 1.
- K830352: Reinforced Silicone Tracheal Tube, Portex, Inc. (1983) Summary page 1.
- (no number) NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed: named in the summary without a submission number

## Indications for use
The device is a single use, sterile, cuffed tracheal tube for tracheal intubation and indicated for airway management.

Source page: https://510kreport.com/device/K955495
Methodology: https://510kreport.com/methodology