# K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Feb 13, 2004 after 51 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- 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: 4 generations back to K920547 (1992). 36 ancestors in all.
6 later devices descend from it; 2 cite it directly.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits, Mentor Medical Limited (2003) Summary page 1.

## Most influential descendants
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K180034: Weinmann Tracheostomy Exchange Set (2018), 1 descendant of its own
- K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (2019), 0 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K040014
Methodology: https://510kreport.com/methodology