# K250173: Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Oct 6, 2025 after 258 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: 7 generations back to K961837 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111401: Bever Endotracheal Tube, Bever Eva Endotracheal Tube, Hangzhou Bever Medical Devices Co., Ltd. (2012) Summary page 6.
- K233341: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410), Covidien, LLC (2024) Summary page 6.

## Indications for use
The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

Source page: https://510kreport.com/device/K250173
Methodology: https://510kreport.com/methodology