# K955680: Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Mar 13, 1996 after 90 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K142298: Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff (2015), 0 descendants of its own

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-1497-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1493-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1499-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1498-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1492-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1496-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1494-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1495-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

Source page: https://510kreport.com/device/K955680
Methodology: https://510kreport.com/methodology