510(k) · Cleared
ClearedCiaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Oct 3, 2007 as substantially equivalent to K041044 (Cook, Inc., 2004) after a 61-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Oct 3, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K920547 (1992). 37 ancestors in all, the oldest K770977 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 4 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- 3 generations backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- 2 generations backK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- 1 generation backK041044 Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004
- This deviceK072148 Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerCook, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK093469 Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer…Cook, Inc. · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K093469Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…Cook, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −4 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| −3 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| −2 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| −1 | K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set | Cook, Inc. | 2004 | — |
| 0 (this device) | K072148 | Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer | Cook, Inc. | 2007 | — |
| +1 | K093469 | Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model… | Cook, Inc. | 2010 | 17 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOH device
- #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetSummary page 1…Introducer is identical in terms of intended use and technological characteristics to the predicate Ciaglia Blue DolphinTM Balloon Percutaneous Tracheostomy Introducer (K041044), and similar in terms of materials of construction. Device Description: The Ciaglia Blue DolphinTM Balloon Percutaneous Trach… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093469 | Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple… | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 37 ancestors have a recall of any class.
- Of its descendants, K093469 (Cook, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Used for controlled elective subcricoid insertion of a tracheostomy tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072148: Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072148
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026