# K142296: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 24, 2015 after 190 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792222 (1979). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962173: Shikey Tracheostomy Tubes and Accessories, Mallinckrodt Medical (1996) Summary page 5.
- K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical (1997) Summary page 5.

## Most influential descendants
- K150844: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (2015), 1 descendant of its own
- K251313: Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (2025), 0 descendants of its own
- K193077: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (2020), 0 descendants of its own

## Recalls of this device
- 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
Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management. Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management. Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures. The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.

Source page: https://510kreport.com/device/K142296
Methodology: https://510kreport.com/methodology