# K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 29, 2004 after 98 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.
2 later devices descend from it; 1 cites it directly.
0 of 39 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.
- (no number) Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer: named in the summary without a submission number

## Most influential descendants
- K072148: Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer (2007), 1 descendant of its own
- K093469: Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple, Prefix C-PTBS (2010), 0 descendants of its own

## Indications for use
The Ciaglia CheetahTM Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.

Source page: https://510kreport.com/device/K041044
Methodology: https://510kreport.com/methodology