510(k) · Cleared
ClearedCiaglia Cheetah Percutaneous Tracheostomy Introducer Set
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 Jul 29, 2004 as substantially equivalent to K022212 (Mentor Medical Limited, 2003) after a 98-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 29, 2004
- Review
- 98 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920547 (1992). 36 ancestors in all, the oldest K770977 (1977). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 3 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- 2 generations backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- 1 generation backK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- This deviceK041044 Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK072148 Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerCook, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK093469 Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer…Cook, Inc. · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −3 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| −2 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| −1 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| 0 (this device) | K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set | Cook, Inc. | 2004 | — |
| +1 | K072148 | Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer | Cook, Inc. | 2007 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K022212 | Portex Percutaneous Dilatational Tracheostomy KitsSummary page 1…hino* Percutaneous Tracheostomy Introducer Class I Exempt Cook Incorporated Portex Ltd. Portex Percutaneous Dilatational Tracheostomy Kit K022212 Device Description; The Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer consists of an… | 2003 |
| * | — | Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072148 | Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy Introducer | 2007 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 36 ancestors have a recall of any class.
- Of its descendants, K072148 (Cook, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K022212.
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.
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?
The Ciaglia CheetahTM Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041044
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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