510(k) · Cleared
ClearedPortex Percutaneous Tracheostomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical International · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Jun 19, 2006 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 19, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK060945 Portex Percutaneous Tracheostomy KitSmiths Medical International · 2006
- 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
- K173912 BLUperc Percutaneous Dilation Tracheostomy Kit…cites it directly · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060945 | Portex Percutaneous Tracheostomy Kit | Smiths Medical International | 2006 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K173912 (Smiths Medical Asd, Inc., 2018) has gone furthest, with 0 descendants of its own.
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?
To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060945: Portex Percutaneous Tracheostomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060945
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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