# K243785: Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye  Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet  Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced   Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye  Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Sep 25, 2025 after 290 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 K790575 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790575: Tube, Armored Tracheal, National Patent Development Corp. (1979) Summary page 6.

## Indications for use
These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

Source page: https://510kreport.com/device/K243785
Methodology: https://510kreport.com/methodology