510(k) · Cleared
ClearedHI-LO Evac and Evac II Endotracheal Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 20, 1997 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 41 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it.
- Decided
- Mar 20, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 7 citing it directly. 4 of the 41 devices in this family, counting this one, have a Class I recall.
- This deviceK965132 HI-LO Evac and Evac II Endotracheal TubesMallinckrodt Medical · 1997
- Descendant · cites it directly · 21 of its ownK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- Descendant · 2 generations on · 12 of its ownK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · cites it directly · 11 of its ownK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · Recalled
- Descendant · cites it directly · 6 of its ownK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
- Descendant · 3 generations on · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 40 · See all- K030570Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003 · cites it directly21descendants
- K032112P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004 · 2 generations on12descendants
- K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · cites it directly11descendants
- K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009 · cites it directly6descendants
- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965132 | HI-LO Evac and Evac II Endotracheal Tubes | Mallinckrodt Medical | 1997 | — |
| +1 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| +2 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +1 | K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | Mallinckrodt Medical | 2008 | 2 |
| +1 | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | Covidien | 2009 | — |
| +3 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 1 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 3 | 0 |
| 2013 | 1 | 1 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 1 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
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 12.6 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (40)
See all 407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | 2003 | 21 |
| K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | 2008 | 11 |
| K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | 2009 | 6 |
| K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | 2012 | 5 |
| K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and… | 2008 | 3 |
| K223130 | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125… | 2023 | 2 |
| K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port Class I | 2009 | 2 |
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.
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 115 Class I recalls
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 2018 · 2 generations on · ◆ in the 2018 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
- K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- Of its descendants, K030570 (Portex, Ltd., 2003) has gone furthest, with 21 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
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/K965132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965132: HI-LO Evac and Evac II Endotracheal Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965132
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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