# K060945: Portex Percutaneous Tracheostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical International
- Decided: Jun 19, 2006 after 74 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K173912: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (2018), 0 descendants of its own
- K083031: Portex Uniperc Percutaneous Dilation Tracheostomy Kit (2009), 0 descendants of its own

## Indications for use
To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.

Source page: https://510kreport.com/device/K060945
Methodology: https://510kreport.com/methodology