510(k) · Cleared
Recalled · Class II · 2026Well Lead Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Instruments · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Feb 18, 2005 as substantially equivalent to K961837 (Rusch Intl., 1996) and 3 other predicates after a 142-day review. Its family tree reaches back 2 generations to 1996. 5 of the 28 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 2005
- Review
- 142 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K961837 (1996). 4 ancestors in all, the oldest K931163 (1993). 23 later devices descend from it, 10 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Recalled (Class I)
- 1 generation backK993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed…Rusch Intl. · 2000 · Recalled (Class I)
- This deviceK042683 Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005
- Descendant · cites it directly · 5 of its ownK111401 Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
- Descendant · 2 generations on · 3 of its ownK151381 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015
- Descendant · cites it directly · 3 of its ownK093126 Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010
- Descendant · 3 generations on · 2 of its ownK223130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™…Covidien · 2023
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…direct predicate · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphydirect predicate · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…direct predicate · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eyedirect predicate · 1993
Most influential descendants
Showing 5 of 23 · See all- K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012 · cites it directly5descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · cites it directly5descendants
- K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015 · 2 generations on3descendants
- K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010 · cites it directly3descendants
- K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125…Covidien · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy | Rusch Intl. | 1996 | Class I |
| −1 | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy | Rusch Intl. | 2000 | Class I |
| 0 (this device) | K042683 | Well Lead Endotracheal Tube | Well Lead Medical Instruments | 2005 | — |
| +1 | K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| +1 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
| +2 | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | Covidien | 2015 | — |
| +1 | K093126 | Anapnoguard Endotracheal Tube | Hospitech Respiration, Ltd. | 2010 | — |
| +3 | K223130 | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP… | Covidien | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 1 |
| 1996 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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 | 1 | 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.
5 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 12.5 · 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphySummary page 1…TR PREDICATE DEVICE: Well Lead is claiming substantial equivalence to the following medical device(s) - * Kendall - Pre-Amendment * RUSCHELIT- K961837, K993786, K961840, K931163, K93786 DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and… | 1996 |
| * | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphySummary page 1…CATE DEVICE: Well Lead is claiming substantial equivalence to the following medical device(s) - * Kendall - Pre-Amendment * RUSCHELIT- K961837, K993786, K961840, K931163, K93786 DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and valve. Th… | 2000 |
| * | K961840 | Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphySummary page 1…CE: Well Lead is claiming substantial equivalence to the following medical device(s) - * Kendall - Pre-Amendment * RUSCHELIT- K961837, K993786, K961840, K931163, K93786 DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and valve. The trachea… | 1996 |
| * | K931163 | Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeSummary page 1…Lead is claiming substantial equivalence to the following medical device(s) - * Kendall - Pre-Amendment * RUSCHELIT- K961837, K993786, K961840, K931163, K93786 DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes m… | 1993 |
| Kept off the family tree | K093786 | Ruschelit Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | — | Kendall - Pre-Amendment Named without a submission number |
What descends from it? (23)
See all 2310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | 2012 | 5 |
| K073383 | Well Lead Reinforced Endotracheal Tube | 2008 | 5 |
| K093126 | Anapnoguard Endotracheal Tube | 2010 | 3 |
| K110269 | Well Lead Endotracheal Tube with Evacuation Lumen-Oral Class I | 2011 | 2 |
| K160694 | Disposable Endotracheal tube, sterile, AccuCuff | 2017 | 1 |
| K140228 | Disposable Tracheal Tube | 2014 | 1 |
| K190213 | Yikang Endotracheal Tube | 2019 | 0 |
| K083119 | Portex Tracheal Tube, Sizes 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 | 2009 | 0 |
| K080105 | Endotracheal Tube | 2009 | 0 |
| K080339 | Medsource Endotracheal Tube (with and Without Cuff) | 2008 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2026 | Class II | Z-3172-2026 | Process control | The 6Fr suction catheter could not pass through the samples smoothly. |
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Direct predicate · ◆ on the line of descent in FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
- K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 4 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K111401 (Hangzhou Bever Medical Devices Co., Ltd., 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K961837.
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 | — |
What is it indicated for?
The device is intended for oral or nasal intubation and for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042683: Well Lead Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042683
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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