510(k) · Cleared
Recalled · 2004Dic Tracheostomy Tube and Portex Blue Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jan 14, 1994 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 14, 1994
- Review
- 123 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK934465 Dic Tracheostomy Tube and Portex Blue LineSmiths Industries Medical Systems, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK955564 Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK964056 Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch…Rusch Intl. · 1997 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK972546 Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998
- Descendant · 2 generations on · 1 of its ownK122235 Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK031057 Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 2003 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K964056 Rusch Ultra Tracheoflex Fenestrated Kit…cites it directly · 1997
Most influential descendants
Showing 5 of 10 · See all- K955564Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996 · cites it directly5descendants
- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy…Rusch Intl. · 1997 · cites it directly4descendants
- K972546Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998 · cites it directly2descendants
- K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013 · 2 generations on1descendant
- K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934465 | Dic Tracheostomy Tube and Portex Blue Line | Smiths Industries Medical Systems, Inc. | 1994 | — |
| +1 | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| +1 | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… | Rusch Intl. | 1997 | Class I |
| +1 | K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | Rusch Intl. | 1998 | — |
| +2 | K122235 | Rusch Tracflex Plus Tracheostomy Tube Set | Teleflexmedical, Inc. | 2013 | — |
| +1 | K031057 | Per-Fit Percutaneous Dilational Tracheostomy Kit | Portex, Inc. | 2003 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | 1996 | 5 |
| K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy… Class I | 1997 | 4 |
| K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | 1998 | 2 |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy Kit | 2003 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2004 | Not classified | Z-0229-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0228-05 | Other | Sterility of the device is compromised due to packaging defects |
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.
- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K955564 (Rusch, Inc., 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K934465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934465: Dic Tracheostomy Tube and Portex Blue Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934465
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026