# K810106: Shiley Single Cannula Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: Feb 2, 1981 after 17 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 5 cite it directly.
3 of 14 devices 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.

## Most influential descendants
- K962173: Shikey Tracheostomy Tubes and Accessories (1996), 7 descendants of its own
- K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula (1997), 5 descendants of its own
- K142296: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula (2015), 3 descendants of its own
- K961449: Tracheostomy Tubes Tracoe-Flex (1996), 3 descendants of its own
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-1484-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1483-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1485-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1482-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1486-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1487-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

Source page: https://510kreport.com/device/K810106
Methodology: https://510kreport.com/methodology