510(k) · Cleared
Recalled · Class II · 2019Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Aug 27, 2003 as substantially equivalent to K912124 (Concord/Portex, 1991) and 2 other predicates after a 203-day review. Its family tree reaches back 3 generations to 1990. 2 of the 15 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 27, 2003
- Review
- 203 days
- Class
- Class II
- Product code
- BTO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K903730 (1990). 6 ancestors in all, the oldest K811033 (1981). 8 later devices descend from it, 4 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 2 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 1 generation backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- This deviceK030381 Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable…Portex, Ltd. · 2003
- 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 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −3 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −2 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −1 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| 0 (this device) | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula | Portex, Ltd. | 2003 | — |
| +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 |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K912124 | Tracheostomy Tube and CuffSummary page 1…Tracheostomy tube. Class I1 BTO, 21 CFR 868.5800 PREDICATE DEVICES: 0 Portex Inc Flexible D.1.C Tracheostomy tube, already marketed in the USA under K912 124 Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, already marketed in the USA under K81103… | 1991 |
| * | K811033 | Shiley Low Pressure Thin-Cuffed TrachSummary page 1…be, already marketed in the USA under K912 124 Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, already marketed in the USA under K811033. Portex Inc. Percutaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube, already marketed in the USA… | 1981 |
| * | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Summary page 1…d in the USA under K811033. Portex Inc. Percutaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube, already marketed in the USA under K980466 0 Portex Inc Steri-Cath Closed Ventilation Suction System already marketed in the USA under K923559 DEVICE DESCRIPTI… | 1998 |
| † | K923559 | Steri-Cath Mdi | 1993 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single… | 2004 | 5 |
| K100283 | Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes… | 2010 | 0 |
| K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy Kit | 2009 | 0 |
| K050166 | Portex Emergency Cricothyroidotomy Kit | 2005 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2019 | Class II | Z-1732-2019 | Error in labeling | Packaged with an incorrect size inner cannula. |
| Mar 7, 2006 | Not classified | Z-0714-06 | Other | Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm |
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 · 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 13 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K041348 (Smiths Medical, 2004) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K912124.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Portex Blue Line Ultra Tracheostomy Tube is indicated for airway maintenance of Tracheostomised patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030381
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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