510(k) · Cleared
ClearedPortex Percutaneous Dilatational Tracheostomy Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Medical Limited · JOH Tube Tracheostomy And Tube Cuff
Cleared on Mar 21, 2003 as substantially equivalent to K011210 (Rusch Intl., 2001) and 6 other predicates after a 256-day review. Its family tree reaches back 3 generations to 1992. 2 of the 46 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Mar 21, 2003
- Review
- 256 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K920547 (1992). 35 ancestors in all, the oldest K770977 (1977). 10 later devices descend from it, 3 citing it directly. 2 of the 46 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 2 generations backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- 1 generation backK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- This deviceK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- Descendant · cites it directly · 6 of its ownK040014 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 · cites it directly · 2 of its ownK041044 Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK180034 Weinmann Tracheostomy Exchange SetCook Incorporated · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd. · 2004 · cites it directly6descendants
- 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
- K041044Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004 · cites it directly2descendants
- K180034Weinmann Tracheostomy Exchange SetCook Incorporated · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −2 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| −1 | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| 0 (this device) | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| +1 | 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 |
| +1 | K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set | Cook, Inc. | 2004 | — |
| +3 | K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018 | — |
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 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011210 | The Percuquick Set for Percutaneous Dilation Tracheostomy | 2001 |
| * | K936133 | Percutaneous Tracheostomy KitSummary page 2…ck Set” Percutaneous Tracheostomy Kit.” Legally marketed in the USA under KO 11210 0 Portex “Per-Fit Percutaneous Tracheostomy Kit” Legally marketed in the USA under K936 133 Kit Component/Element Predicates: ComDonentElement Predicate Hydrophilic coating for Mallinck… | 1994 |
| * | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterSummary page 2…llinckrodt “Finch” and “Copperhead” Percutaneous Serial Dilatorshtroducers Transluminal Angioplasty Catheters already marketed in the USA under K983830 Scalpel MaersWParagon Single Use Scalpel already sold into USA under device listing R… | 1999 |
| * | K852444 | Asik 'Once' SyringeSummary page 2…USA under device listing R027050. Syringe A S K ‘ONCE’ Syringe already marketed in the USA under K852444 Guidewire materials TFX guidewire already marketed in the USA under K963320 14G Needle… | 1985 |
| * | K963320 | TFX Medical GuidewireSummary page 2…keted in the USA under K852444 Guidewire materials TFX guidewire already marketed in the USA under K963320 14G Needle and Cannula Wallace IV Cannula already marketed in the USA under materials K932946 14Fr P… | 1996 |
| * | K932946 | Wallace IV CannulaSummary page 2…in the USA under K963320 14G Needle and Cannula Wallace IV Cannula already marketed in the USA under materials K932946 14Fr Pre-dilator materials Base Polymer - Portex Adjustable Flange Tracheostomy tube already ma… | 1995 |
| * | K962175 | Portex Adjustable Flange Tracheostomy TubeSummary page 2…K932946 14Fr Pre-dilator materials Base Polymer - Portex Adjustable Flange Tracheostomy tube already marketed in the USA under K962175. Colourant - Portex Y-Cann already marketed in the USA under KO32047… | 1997 |
| Kept off the family tree | K032047 | FDA’s K032047 is Tri-Loop Microwave Ablation Probe Our reading of the summary gave K032047, which FDA decided on Aug 6, 2003, after this device was decided (Mar 21, 2003), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. | 2003 |
| * | — | Maersk/Paragon Single Use Scalpel Named without a submission number |
What descends from it? (10)
3 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 11 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 35 ancestors have a recall of any class.
- Of its descendants, K040014 (Portex, Ltd., 2004) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K011210.
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, dilators, 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/K022212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022212: Portex Percutaneous Dilatational Tracheostomy Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022212
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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