# K903435: Shiley Specialized Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: Oct 2, 1990 after 63 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-1509-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1521-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1501-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1516-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1517-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1508-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1519-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1504-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1503-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1502-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1505-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1507-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1523-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1500-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1518-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1515-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1520-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1506-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1522-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

Source page: https://510kreport.com/device/K903435
Methodology: https://510kreport.com/methodology