510(k) · Cleared
ClearedBever Endotracheal Tube, Bever Eva Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Bever Medical Devices Co., Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jul 19, 2012 as substantially equivalent to K042683 (Well Lead Medical Instruments, 2005) and 1 other predicate after a 427-day review. Its family tree reaches back 3 generations to 1996. 4 of the 12 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 19, 2012
- Review
- 427 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961837 (1996). 6 ancestors in all, the oldest K931163 (1993). 5 later devices descend from it, 3 citing it directly. 4 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 deviceK111401 Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK151381 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015
- Descendant · 2 generations on · 2 of its ownK223130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™…Covidien · 2023
- Descendant · 3 generations on · 1 of its ownK233341 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP…Covidien, LLC · 2024
- Descendant · cites it directly · 0 of its ownK250173 Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™…Covidien, LLC · 2025
- Descendant · cites it directly · 0 of its ownK190630 SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC · 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 5 of 5 · See all- K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeCovidien · 2015 · cites it directly3descendants
- K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125…Covidien · 2023 · 2 generations on2descendants
- K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…Covidien, LLC · 2024 · 3 generations on1descendant
- K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal…Covidien, LLC · 2025 · cites it directly0descendants
- K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC · 2019 · cites it directly0descendants
View 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) | K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| +1 | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | Covidien | 2015 | — |
| +2 | K223130 | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP… | Covidien | 2023 | — |
| +3 | K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430… | Covidien, LLC | 2024 | — |
| +1 | K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE… | Covidien, LLC | 2025 | — |
| +1 | K190630 | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 1 |
| 1996 | 1 | 1 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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.
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 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…ector) (21 CFR 868.5730, Product Code BTR) 4. Predicate Device: BEVER is claiming substantial equivalence to the following medical devices: Well lead Endotracheal tube - K042683 Hi-Lo Evac TM Endotracheal Tube - K965 132 5. Device Description BEVERM Endotracheal Tube with cuff (Oral/Nasal) is available in… | 2005 |
| * | K965132 | HI-LO Evac and Evac II Endotracheal TubesSummary page 1…4. Predicate Device: BEVER is claiming substantial equivalence to the following medical devices: Well lead Endotracheal tube - K042683 Hi-Lo Evac TM Endotracheal Tube - K965 132 5. Device Description BEVERM Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm ~-10.0 mm in 0.5 mmn increments… | 1997 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- 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 16 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 5 of the 6 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K151381 (Covidien, 2015) has gone furthest, with 3 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. 2012, 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 BEVERm Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during mechanical ventilation and anesthesia.
BEVER Evam Endotracheal Tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the contaminated mucous and subglottic secretion that accumulate above the cuff by continuous or intermittent suctioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111401: Bever Endotracheal Tube, Bever Eva 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/K111401
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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