510(k) · Cleared
Recalled · Class II · 2017Portex Adjustable Flange Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jan 17, 1997 after a 226-day review. The FDA summary names its predicate without a number. 2 of the 24 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 1997
- Review
- 226 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1
- Predicates
- 0
23 later devices descend from it, 3 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- This deviceK962175 Portex Adjustable Flange Tracheostomy TubeSmiths Industries Medical Systems, Inc. · 1997
- Descendant · cites it directly · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · cites it directly · 10 of its ownK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- Descendant · 2 generations on · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- Descendant · 2 generations on · 6 of its ownK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- Descendant · 2 generations on · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · cites it directly12descendants
- K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003 · cites it directly10descendants
- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · 2 generations on6descendants
- K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd. · 2004 · 2 generations on6descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962175 | Portex Adjustable Flange Tracheostomy Tube | Smiths Industries Medical Systems, Inc. | 1997 | — |
| +1 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +1 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| +2 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| +2 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| +2 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 1 |
| 2019 | 3 | 1 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | — | PORTEX® Blue Line™ Tracheostomy Tube Named without a submission number | |
| * | — | BIVONA Hyperflex Tracheostomy Tube Adjustable Neckflange Named without a submission number |
What descends from it? (23)
See all 233 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2017 | Class II | Z-3213-2017 | Under Investigation by firm | Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm… |
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 · 3 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K032112 (Portex, Ltd., 2004) has gone furthest, with 12 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.
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 PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962175: Portex Adjustable Flange Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962175
Report an extraction error
Are you the manufacturer?
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