510(k) · Cleared
ClearedDouble Lumen Tracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Catheter Co. Div. Mallinckrodt · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 13, 1981 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 13, 1981
- Review
- 149 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK802505 Double Lumen Tracheal TubeNational Catheter Co. Div. Mallinckrodt · 1981
- Descendant · cites it directly · 1 of its ownK040657 Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and…Vygon SA · 2004
- Descendant · 2 generations on · 0 of its ownK211543 Wei Nasal Jet TubeWell Lead Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK021044 MadettWolfe Tory Medical, Inc. · 2002 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802505 | Double Lumen Tracheal Tube | National Catheter Co. Div. Mallinckrodt | 1981 | — |
| +1 | K040657 | Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80 | Vygon SA | 2004 | — |
| +2 | K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022 | — |
| +1 | K021044 | Madett | Wolfe Tory Medical, Inc. | 2002 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2022 | 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.
Planning a device in BTR? 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 12.5 · 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040657 (Vygon SA, 2004) has gone furthest, with 1 descendant 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/K802505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K802505: Double Lumen Tracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802505
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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