# K142298: Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 13, 2015 after 179 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K081440 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955680: Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed, Mallinckrodt Medical (1996) Summary page 4.
- K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T, Covidien (2012) Summary page 4.
- K083641: Bivona Tracheostomy Tubes, Smiths Medical Asd, Inc. (2009) Summary page 4.

## Recalls of this device
- May 8, 2015 · Class I · Z-1950-2015: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, correspo

## Indications for use
The Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.

Source page: https://510kreport.com/device/K142298
Methodology: https://510kreport.com/methodology