# K083031: Portex Uniperc Percutaneous Dilation Tracheostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 18, 2009 after 312 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K920547 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only, Portex, Ltd. (2004)
- K060945: Portex Percutaneous Tracheostomy Kit, Smiths Medical International (2006) Summary page 1.
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra, Smiths Medical (2004) Summary page 1.
- K946289: Devons Point Lok Needle Protection Device, Devon Industries, Inc. (1995) Summary page 1.
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula, Portex, Ltd. (2003) Summary page 1.
- K962175: Portex Adjustable Flange Tracheostomy Tube, Smiths Industries Medical Systems, Inc. (1997) Summary page 1.
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed), Portex, Ltd. (2004) Summary page 1.
- (no number) Kapitex Inner Cannula Cleaning Swabs: named in the summary without a submission number

## Indications for use
Portex® UniPercTM single use Percutaneous Dilation Tracheostomy Kits allows the controlled, elective subcricoid percutaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldinger guidewire dilation technique in patients with a large neck anatomy (up to a maximum of 50mm of pre-tracheal soft tissue anterior to the trachea) where standard length flange tracheostomy tubes are too short. Tracheostomy tube maximum period of use 29 days.

Source page: https://510kreport.com/device/K083031
Methodology: https://510kreport.com/methodology