510(k) · Cleared
ClearedPortex Blue Line Ultra Paediatric Tracheosomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Dec 7, 2017 as substantially equivalent to K912469 (Bivona Medical Technologies, 1991) and 1 other predicate after a 273-day review. Its family tree reaches back 3 generations to 2008. 2 of the 6 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 7, 2017
- Review
- 273 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K081440 (2008). 5 ancestors in all, the oldest K912469 (1991). No later device cites it as a predicate yet. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK081440 Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy TubesSmiths Medical Asd, Inc. · 2008 · Recalled
- 2 generations backK083641 Bivona Tracheostomy TubesSmiths Medical Asd, Inc. · 2009 · Recalled
- 1 generation backK122531 Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · Recalled (Class I)
- This deviceK170720 Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K081440 | Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2008 | 1 |
| −2 | K083641 | Bivona Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2009 | 3 |
| −1 | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube… | Covidien | 2012 | Class I |
| 0 (this device) | K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 1 |
| 1995 | 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 |
|---|---|---|---|
| * | K912469 | Bivona Wire Reinforced Pediatric Tracheostomy TubeSummary page 5…e Date Bivona Uncuffed Pediatric JOH Tracheostomy Tube (wire reinforced) K912469 21 CFR Original Applicant: Bivona Medical… | 1991 |
| * | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…Summary page 5…iley Neonatal, Pediatric, Pediatric JOH Long Tracheostomy Tube Cuffless K122531 21 CFR Original Applicant: Covidien… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K912469Bivona Wire Reinforced Pediatric Tracheostomy TubeBivona Medical Technologies · 1991 · Direct predicate · ◆ in the 1991 ancestors bar of FIG. 128 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K912469.
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. 2017, this device’s year, is highlighted.
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?
Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170720: Portex Blue Line Ultra Paediatric Tracheosomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170720
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