510(k) · Cleared
Recalled · Class II · 2016Sealguard Evac Endotracheal and 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 Oct 2, 2008 as substantially equivalent to K871204 (Mallinckrodt Critical Care, 1987) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1987. 2 of the 14 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 2, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871204 (1987). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK871204 Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care · 1987 · Recalled
- This deviceK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008
- Descendant · cites it directly · 6 of its ownK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
- Descendant · cites it directly · 3 of its ownK093126 Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010
- Descendant · 2 generations on · 2 of its ownK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK110269 Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK180991 AG 100sHospitech Respiration, Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009 · cites it directly6descendants
- K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010 · cites it directly3descendants
- K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016 · 2 generations on2descendants
- K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. · 2011 · 2 generations on2descendants
- K180991AG 100sHospitech Respiration, Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871204 | Cuffed Tracheal Tube (Multiple) | Mallinckrodt Critical Care | 1987 | 1 |
| 0 (this device) | K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | Mallinckrodt Medical | 2008 | — |
| +1 | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | Covidien | 2009 | — |
| +1 | K093126 | Anapnoguard Endotracheal Tube | Hospitech Respiration, Ltd. | 2010 | — |
| +2 | K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration, Ltd. | 2016 | — |
| +2 | K110269 | Well Lead Endotracheal Tube with Evacuation Lumen-Oral | Well Lead Medical Co., Ltd. | 2011 | Class I |
| +3 | K180991 | AG 100s | Hospitech Respiration, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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.
2 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 |
|---|---|---|---|
| * | K871204 | Cuffed Tracheal Tube (Multiple)Summary page 2…ine to assist in radiographic visualization. 8. Substantial Equivalence The predicate devices to which we claim equivalence are the Hi-Lo Cuffed Tracheal Tube (K871204), and the Hi-Lo Evac Endotracheal Tubes (K965132). The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes m… | 1987 |
| * | K965132 | HI-LO Evac and Evac II Endotracheal TubesSummary page 2…8. Substantial Equivalence The predicate devices to which we claim equivalence are the Hi-Lo Cuffed Tracheal Tube (K871204), and the Hi-Lo Evac Endotracheal Tubes (K965132). The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes maintain the same intended use as the predicate… | 1997 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2016 | Class II | Z-1626-2016 | Process control | Device packaging may not be sealed. |
| Apr 4, 2016 | Class II | Z-1625-2016 | Process control | Device packaging may not be sealed. |
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.
- 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?
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. 2008, 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 SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.
The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082520: Sealguard Evac Endotracheal and Endotracheal Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082520
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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