# K223130: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 30, 2023 after 331 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: 5 generations back to K961837 (1996). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151381: Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye, Covidien (2015) Summary page 5.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 5.

## Most influential descendants
- 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) (2024), 1 descendant of its own
- 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) (2025), 0 descendants of its own

## Indications for use
The Shiley ™ pediatric oral/nasal endotracheal tube with TaperGuard ™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

Source page: https://510kreport.com/device/K223130
Methodology: https://510kreport.com/methodology