# K132415: Rusch Safety Silk Series Oral/Nasal Tracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 6, 2014 after 308 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: 2 generations back to K961837 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy, Rusch Intl. (2000) Summary page 1.
- K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy, Rusch Intl. (1996) Summary page 1.

## Indications for use
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.

Source page: https://510kreport.com/device/K132415
Methodology: https://510kreport.com/methodology