510(k) · Cleared
ClearedPercutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Feb 13, 2004 as substantially equivalent to K022212 (Mentor Medical Limited, 2003) after a 51-day review. Its family tree reaches back 4 generations to 1992. 2 of the 43 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 51 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). 6 later devices descend from it, 2 citing it directly. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- 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 deviceK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK133597 Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue…Cook, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK180034 Weinmann Tracheostomy Exchange SetCook Incorporated · 2018
- Descendant · 3 generations on · 0 of its ownK193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue…Cook Incorporated · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK173912 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube…Smiths Medical Asd, Inc. · 2018 · Recalled (Class I)
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical · 2004 · cites it directly5descendants
- K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc. · 2014 · 2 generations on2descendants
- K180034Weinmann Tracheostomy Exchange SetCook Incorporated · 2018 · 3 generations on1descendant
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated · 2019 · 3 generations on0descendants
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc. · 2018 · 2 generations on0descendants
View 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) | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| +1 | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | 1 |
| +2 | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino… | Cook, Inc. | 2014 | 1 |
| +3 | K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018 | — |
| +3 | K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino… | Cook Incorporated | 2019 | Class I |
| +2 | K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc… | Smiths Medical Asd, Inc. | 2018 | Class I |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 1 |
| 2019 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K022212 | Portex Percutaneous Dilatational Tracheostomy KitsSummary page 1…CES The proposed device, the "Portex Percutaneous Dilation Tracheostomy Kit with Serial Dilators for Sizes 7, 8 & 9mm tubes only, without Tracheostomy Tube" (k022212) DESCRIPTION: The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insert… | 2003 |
| † | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and… | 1998 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
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, K041348 (Smiths Medical, 2004) has gone furthest, with 5 descendants 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?
To create a percutaneous dilational tracheostomy using guidewire,
single stage dilator and components of this product which allows for tracheal access for
airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040014
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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