# K093469: Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple, Prefix C-PTBS

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jan 8, 2010 after 63 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K920547 (1992). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072148: Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer, Cook, Inc. (2007) Summary page 1.

## Recalls of this device
- Apr 21, 2010 · Not classified · Z-2088-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2089-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2085-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2084-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2090-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2079-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2091-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2077-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2087-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2076-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2081-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2080-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2086-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2083-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2078-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2092-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu
- Apr 21, 2010 · Not classified · Z-2082-2010: These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a resu

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

Source page: https://510kreport.com/device/K093469
Methodology: https://510kreport.com/methodology