510(k) · Cleared
Recalled · Class I · 2023Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 16, 1996 after a 95-day review. The FDA summary names its predicate without a number. 3 of the 31 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled 36 times, including 32 Class I recalls.
- Decided
- Aug 16, 1996
- Review
- 95 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 36 (32 Class I)
- Predicates
- 0
30 later devices descend from it, 5 citing it directly. 3 of the 31 devices in this family, counting this one, have a Class I recall.
- This deviceK961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996
- Descendant · cites it directly · 29 of its ownK993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed…Rusch Intl. · 2000 · Recalled (Class I)
- Descendant · cites it directly · 23 of its ownK042683 Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · Recalled
- Descendant · 2 generations on · 5 of its ownK111401 Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
- Descendant · 3 generations on · 3 of its ownK151381 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
2000high 4 (2019) · low 0 (2001)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · cites it directly29descendants
- K042683Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · cites it directly23descendants
- K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012 · 2 generations on5descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · 2 generations on5descendants
- K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy | Rusch Intl. | 1996 | — |
| +1 | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy | Rusch Intl. | 2000 | Class I |
| +1 | K042683 | Well Lead Endotracheal Tube | Well Lead Medical Instruments | 2005 | 1 |
| +2 | K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| +2 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
| +3 | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | Covidien | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
3 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 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? (1)
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 |
|---|---|---|---|
| * | — | Sheridan HVT (TM) Tracheal Tube with X-Ray Line and 15mm. Connector High Volume Tapered… Named without a submission number |
What descends from it? (30)
See all 305 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy Class I | 2000 | 29 |
| K042683 | Well Lead Endotracheal Tube | 2005 | 23 |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch… | 2025 | 0 |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | 2015 | 0 |
| K132415 | Rusch Safety Silk Series Oral/Nasal Tracheal Tube | 2014 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2023 | Class I | Z-1882-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1852-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1886-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1899-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1962-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1881-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1960-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1961-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1889-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1963-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1890-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1847-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1965-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1892-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1846-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1888-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1958-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1964-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1893-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1849-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1894-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1887-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1850-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1853-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1848-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1959-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1851-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1891-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1883-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1884-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1845-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| May 25, 2023 | Class I | Z-1885-2023 | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| Dec 8, 2022 | Class II | Z-1011-2023 | Process control | Potential for pilot balloon non-inflation or cuff non-deflation. |
| Jul 16, 2021 | Class II | Z-2322-2021 | Process control | The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. |
| Jul 16, 2021 | Class II | Z-2321-2021 | Process control | The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. |
| Jul 16, 2021 | Class II | Z-2320-2021 | Process control | The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. |
The 5 latest of 36 recalls; the web page lists all.
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.
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 13 Class I recalls
- K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K993786 (Rusch Intl., 2000) has gone furthest, with 29 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
2007high 7 (2008) · low 1 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
2007high 308 (2014) · low 61 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
2007high 21 (2009) · low 0 (2008)2026
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
2007high 1,799 (2025) · low 136 (2007)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 | — |
What is it indicated for?
The device is intended for oral or nasal intubation. It is intended for airway management.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961837
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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