# K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Oct 9, 2012 after 50 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: 2 generations back to K081440 (2008). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945513: Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube, Mallinckrodt Medical (1995) Summary page 1.
- K083641: Bivona Tracheostomy Tubes, Smiths Medical Asd, Inc. (2009) Summary page 2.

## Most influential descendants
- K170720: Portex Blue Line Ultra Paediatric Tracheosomy Tube (2017), 0 descendants of its own
- K142298: Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff (2015), 0 descendants of its own

## Recalls of this device
- May 8, 2015 · Class I · Z-1951-2015: 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
This device is intended for use in providing tracheal access for airway management.

Source page: https://510kreport.com/device/K122531
Methodology: https://510kreport.com/methodology