510(k) · Cleared
Recalled · Class II · 2021Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jul 13, 2004 as substantially equivalent to K022212 (Mentor Medical Limited, 2003) and 5 other predicates after a 54-day review. Its family tree reaches back 5 generations to 1992. 2 of the 50 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K920547 (1992). 44 ancestors in all, the oldest K770977 (1977). 5 later devices descend from it, 3 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- 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 backK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- This deviceK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004
- Descendant · cites it directly · 2 of its ownK133597 Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue…Cook, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK180034 Weinmann Tracheostomy Exchange SetCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue…Cook Incorporated · 2019 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK173912 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube…Smiths Medical Asd, Inc. · 2018 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK083031 Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc. · 2009
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc. · 2014 · cites it directly2descendants
- K180034Weinmann Tracheostomy Exchange SetCook Incorporated · 2018 · 2 generations on1descendant
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated · 2019 · 2 generations on0descendants
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc. · 2018 · cites it directly0descendants
- K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc. · 2009 · 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 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| 0 (this device) | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | — |
| +1 | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino… | Cook, Inc. | 2014 | 1 |
| +2 | K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018 | — |
| +2 | K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino… | Cook Incorporated | 2019 | Class I |
| +1 | K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc… | Smiths Medical Asd, Inc. | 2018 | Class I |
| +1 | K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy Kit | Smiths Medical Asd, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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…in the 1. Portex Ltd: Portcx Percutaneous Dilation Trachcostom> Kit with Serial Dilators. already marketed USA under K022212 in 2. Portex… | 2003 |
| * | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Summary page 1…in 2. Portex Ltd: Ponex Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator already marketed the USA under K040014 K030381 3. Portex Ltd: Blue Li… | 2004 |
| * | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaSummary page 1…Kit with Single Stage Dilator already marketed the USA under K040014 K030381 3. Portex Ltd: Blue Line Ultra Tracheostomy Tube kits. already marketed in the USA under 4. Portex Inc. Percutaneous Dil… | 2003 |
| * | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Summary page 1…marketed in the USA under 4. Portex Inc. Percutaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube (Perfit) already marketed in the USA under K980466 5. Rusch Percuquick set for percutaneous dilation tracheostorny already marketed in the USA under KOI 1210 6 Shiley Lo… | 1998 |
| * | K011210 | The Percuquick Set for Percutaneous Dilation Tracheostomy | 2001 |
| * | K880247 | Modified Shiley Low Pressure Cuffed Tracheo. TubesSummary page 1…for percutaneous dilation tracheostorny already marketed in the USA under KOI 1210 6 Shiley Low%Pressure Cuffed imcheostomy tube already marketed in the USA under K880247 Section 5 - Page I of 2 Smiths Medical: Portcx Percutaneo… | 1988 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous… | 2014 | 2 |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous… Class I | 2018 | 0 |
| K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy Kit | 2009 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2021 | Class II | Z-1993-2021 | Labeling mix-ups | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit. |
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 · Cites it directly · ◆ 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 · 2 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 6 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 44 ancestors have a recall of any class.
- Of its descendants, K133597 (Cook, Inc., 2014) has gone furthest, with 2 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?
The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer are indicated to create a percutaneous dilational tracheostomy using guidewire dilator/s and components of these kits that allow for tracheal access for airway management for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041348
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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