Portex Uniperc Percutaneous Dilation Tracheostomy Kit
by Smiths Medical Asd, Inc. 510(k)
Active
510(k) K083031
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083031 | Date18 Aug 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BTO
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5800
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a percutaneous dilation tracheostomy kit, specifically the Portex Uniperc model, designed for airway management via a Seldinger guidewire dilation technique. It is intended for the controlled, elective subcricoid percutaneous insertion of an adjustable flange tracheostomy tube in patients with large necks and a minimum of 50mm of pre-tracheal soft tissue.
The kit is supplied as a single-use, sterile device for bedside use in clinical settings. It has received FDA 510(k) clearance (K083031) and is classified as a Class II medical device under regulation number 868.5800. The device is manufactured by Smiths Medical Asd, Inc. and is not indicated for MRI safety or reuse.
Other devices from Smiths Medical Asd, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Portex Uniperc Percutaneous Dilation Tracheostomy Kit used for?
It is designed for the controlled, elective subcricoid percutaneous insertion of an adjustable flange tracheostomy tube using a Seldinger guidewire dilation technique, specifically in patients with large necks and a minimum of 50mm of pre-tracheal soft tissue to facilitate airway management.
Is the Portex Uniperc kit sterile and intended for single use or reuse?
The kit is supplied as a single-use, sterile device, meaning it is sterilized prior to use and must be discarded after one procedure; it is not indicated for reuse due to infection risk and design limitations.
What clinical setting is the Portex Uniperc kit appropriate for, and what technique does it employ?
It is intended for bedside use in clinical settings and employs a Seldinger guidewire dilation technique to allow percutaneous dilation tracheostomy insertion under controlled conditions.