Covidien, LLC · Class II · Cleared Dec 29, 2025
| K-number | K251313 |
| Device name | 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 |
| Applicant | Covidien, LLC |
| Product code | JOH |
| Device class | Class II |
| Decision date | Dec 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5800 |
The Shiley Adult Flexible Tracheostomy Tube XLT with Disposable Inner Cannula is a sterile, single-use dual cannula tracheostomy tube with a 90-degree curve and a distal or proximal extension designed for patients with challenging airway anatomy. The device provides tracheal access for airway management and is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
The subject device features a biocompatible radiopaque outer cannula made of non-DEHP PVC, a flexible laser-etched flange with integrated 15mm connector, flexible disposable inner cannula, and a low-pressure TaperGuard cuff (in cuffed configurations). It is available in four sizes (5.0mm to 8.0mm), offers both cuffed and cuffless configurations with distal or proximal extensions, and is sterilized via ethylene oxide to a SAL of 10-6. Key differences from the predicate include a narrower size range and four distinct configurations versus two.
ISO 5366 (tracheostomy tubes), ISO 5356-1 (tube connectors), ISO 10993-1 (biocompatibility), ISO 18562-1 (particulate matter and volatile organic compounds), EN 62366-1:2015+A1:2020 and IEC 62366-1:2015+A1:2020 (human factors), and FDA guidance on use of international standards.
The subject device is substantially equivalent to predicate K142296 because both share the same intended use (tracheal access for airway management), similar indications for use including PDT procedures, and identical technological characteristics including radiopaque outer cannula, low-pressure TaperGuard cuff, non-DEHP PVC materials, disposable inner cannula, and MRI compatibility. Reference devices K051416 and K150844 further support equivalence by demonstrating that the distal/proximal extension configurations, 90-degree curve, and smaller size range (5.0–8.0mm) are established and safe design features. The different technological characteristics do not raise different safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov