# K880247: Modified Shiley Low Pressure Cuffed Tracheo. Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: Feb 12, 1988 after 23 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.
7 later devices descend from it; 2 cite it directly.
2 of 8 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
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K180034: Weinmann Tracheostomy Exchange Set (2018), 1 descendant of its own
- K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (2019), 0 descendants of its own
- K173912: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K880247
Methodology: https://510kreport.com/methodology