# K030787: Shiley Flextra Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 14, 2003 after 247 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (0 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). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003315: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt, Inc. (2000)
- K962173: Shikey Tracheostomy Tubes and Accessories, Mallinckrodt Medical (1996) Summary page 1.
- K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical (1997) Summary page 1.
- K880247: Modified Shiley Low Pressure Cuffed Tracheo. Tubes, Shiley, Inc. (1988) Summary page 1.
- K811447: Shiley Disposable Cannula Trach. Tube, Shiley, Inc. (1981) Summary page 1.
- K810106: Shiley Single Cannula Tracheostomy Tube, Shiley, Inc. (1981) Summary page 1.

## Recalls of this device
- Dec 9, 2004 · Not classified · Z-0721-05: Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.

## Indications for use
The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management. Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

Source page: https://510kreport.com/device/K030787
Methodology: https://510kreport.com/methodology