# K150844: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jul 14, 2015 after 106 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K792222 (1979). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142296: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula, Covidien (2015) Summary page 4.
- K962173: Shikey Tracheostomy Tubes and Accessories, Mallinckrodt Medical (1996) Summary page 4.

## Most influential descendants
- K193077: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (2020), 0 descendants of its own

## Recalls of this device
- Feb 26, 2025 · Class I · Z-1390-2025: Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, 
- Mar 24, 2023 · Class I · Z-1357-2023: A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components

## Indications for use
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management. The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures. The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

Source page: https://510kreport.com/device/K150844
Methodology: https://510kreport.com/methodology