510(k) · Cleared
ClearedD.I.C. Tracheostomy Tubes & Laryngectomy Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concord/Portex · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Sep 25, 1990 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 39 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it.
- Decided
- Sep 25, 1990
- Review
- 40 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 4 citing it directly. 4 of the 39 devices in this family, counting this one, have a Class I recall.
- This deviceK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- Descendant · cites it directly · 32 of its ownK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- Descendant · 2 generations on · 31 of its ownK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- Descendant · 3 generations on · 21 of its ownK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- Descendant · 4 generations on · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · 3 generations on · 8 of its ownK030381 Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable…Portex, Ltd. · 2003 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K173384 BLUselect, non-fenestrated, BLUselect…4 generations on · 2018
- K173912 BLUperc Percutaneous Dilation Tracheostomy Kit…4 generations on · 2018
- K091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with…5 generations on · 2009
- K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy…5 generations on · 2019
Most influential descendants
Showing 5 of 38 · See all- K960429Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner CannulaSmiths Industries Medical Systems, Inc. · 1996 · cites it directly32descendants
- K980466Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and…Sims Portex, Inc. · 1998 · 2 generations on31descendants
- K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003 · 3 generations on21descendants
- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · 4 generations on12descendants
- K030381Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex, Ltd. · 2003 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| +1 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| +2 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| +3 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| +4 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +3 | K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula | Portex, Ltd. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 2 |
| 2019 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
4 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (38)
See all 384 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner Cannula | 1996 | 32 |
| K961449 | Tracheostomy Tubes Tracoe-Flex | 1996 | 3 |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy Kit | 2003 | 1 |
| K970811 | Disposable Cannula Tracheostomy Tube, with Inner Cannula;Disposable Cannula Fenestrated… | 1998 | 0 |
Has anything in its family been recalled? (4 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.
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 115 Class I recalls
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K960429 (Smiths Industries Medical Systems, Inc., 1996) has gone furthest, with 32 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 | — |
https://510kreport.com/device/K903730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903730
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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