# K072148: Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Oct 3, 2007 after 61 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: 5 generations back to K920547 (1992). 37 ancestors in all.
1 later device descends 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)
- K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set, Cook, Inc. (2004) Summary page 1.

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

## Indications for use
Used for controlled elective subcricoid insertion of a tracheostomy tube.

Source page: https://510kreport.com/device/K072148
Methodology: https://510kreport.com/methodology