510(k) · Cleared
Recalled · Class I · 2024Well Lead Endotracheal Tube with Evacuation Lumen-Oral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 26, 2011 as substantially equivalent to K042683 (Well Lead Medical Instruments, 2005) and 1 other predicate after a 211-day review. Its family tree reaches back 3 generations to 1996. 5 of the 12 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 26, 2011
- Review
- 211 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961837 (1996). 9 ancestors in all, the oldest K871204 (1987). 2 later devices descend from it, 2 citing it directly. 5 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Recalled (Class I)
- 2 generations backK993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed…Rusch Intl. · 2000 · Recalled (Class I)
- 1 generation backK042683 Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · Recalled
- This deviceK110269 Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK190878 Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with…Salter Labs, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK182739 Endotracheal Tube with Evacuation LumenWell Lead Medical Co., Ltd. · 2019
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…2 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy2 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…2 generations back · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye2 generations back · 1993
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy | Rusch Intl. | 1996 | Class I |
| −2 | 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 |
| 0 (this device) | K110269 | Well Lead Endotracheal Tube with Evacuation Lumen-Oral | Well Lead Medical Co., Ltd. | 2011 | — |
| +1 | K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter… | Salter Labs, Inc. | 2020 | — |
| +1 | K182739 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 1 |
| 1996 | 1 | 1 |
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K042683 | Well Lead Endotracheal TubeSummary page 1…n Common Name: Endotracheal Tube with Evacuation Lumen Classification Name: Tube, tracheal (w/wo connector) (21 CFR 878.5730, Product Code FMC73 BTR) Predicate Device: K042683-WELL LEAD ENDOTRACHEAL TUBE K090352-Taperguard EvaJ"v Endotracheal Tubes Device Description: Well Lead Endotracheal lThbe with… | 2005 |
| * | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesSummary page 1…h Evacuation Lumen Classification Name: Tube, tracheal (w/wo connector) (21 CFR 878.5730, Product Code FMC73 BTR) Predicate Device: K042683-WELL LEAD ENDOTRACHEAL TUBE K090352-Taperguard EvaJ"v Endotracheal Tubes Device Description: Well Lead Endotracheal lThbe with Evacuation Lumen-Oral (6.0, 6.5, 7.0… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2024 | Class I | Z-1876-2024 | Under Investigation by firm | Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is… |
| Jun 2, 2016 | Class II | Z-2243-2016 | Nonconforming Material/Component | Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use. |
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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ on the line of descent in FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 7 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K190878 (Salter Labs, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K042683.
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. 2011, this device’s year, is highlighted.
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 intiibation and drainage of the subglottic space for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110269
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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