# K022212: Portex Percutaneous Dilatational Tracheostomy Kits

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Medical Limited
- Decided: Mar 21, 2003 after 256 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: 3 generations back to K920547 (1992). 35 ancestors in all.
10 later devices descend from it; 3 cite it directly.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011210: The Percuquick Set for Percutaneous Dilation Tracheostomy, Rusch Intl. (2001)
- K936133: Percutaneous Tracheostomy Kit, Smiths Industries Medical Systems, Inc. (1994) Summary page 2.
- K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter, Mallinckroot, Inc. (1999) Summary page 2.
- K852444: Asik 'Once' Syringe, Pharma-Plast USA, Inc. (1985) Summary page 2.
- K963320: TFX Medical Guidewire, Tfx Medical Group (1996) Summary page 2.
- K932946: Wallace IV Cannula, Smiths Industries Medical Systems, Inc. (1995) Summary page 2.
- K962175: Portex Adjustable Flange Tracheostomy Tube, Smiths Industries Medical Systems, Inc. (1997) Summary page 2.
- (no number) Maersk/Paragon Single Use Scalpel: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K032047: Tri-Loop Microwave Ablation Probe, Vivant Medical, Inc. (2003). Our reading of the summary gave K032047, which FDA decided on Aug 6, 2003, after this device was decided (Mar 21, 2003), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.

## Most influential descendants
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- 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
- K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set (2004), 2 descendants of its own
- K180034: Weinmann Tracheostomy Exchange Set (2018), 1 descendant of its own

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

Source page: https://510kreport.com/device/K022212
Methodology: https://510kreport.com/methodology