# K811033: Shiley Low Pressure Thin-Cuffed Trach

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: May 13, 1981 after 28 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 4 cite it directly.
7 of 42 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
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (2003), 8 descendants of its own
- K962173: Shikey Tracheostomy Tubes and Accessories (1996), 7 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own

Source page: https://510kreport.com/device/K811033
Methodology: https://510kreport.com/methodology