# K193077: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jun 1, 2020 after 209 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- 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
Longest line of descent: 5 generations back to K903730 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
4 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173384: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube, Smiths Medical Ads, Inc. (2018) Summary page 4.
- K150844: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula, Covidien (2015) Summary page 4.

## Indications for use
Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

Source page: https://510kreport.com/device/K193077
Methodology: https://510kreport.com/methodology