510(k) · Cleared
ClearedAnapnoguard Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospitech Respiration, Ltd. · BTP Dropper, Ether
Cleared on Mar 2, 2010 as substantially equivalent to K082520 (Mallinckrodt Medical, 2008) and 1 other predicate after a 151-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. 3 later devices descend from it.
- Decided
- Mar 2, 2010
- Review
- 151 days
- Class
- Class I
- Product code
- BTP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961837 (1996). 8 ancestors in all, the oldest K871204 (1987). 3 later devices descend from it, 1 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 deviceK093126 Anapnoguard Endotracheal TubeHospitech Respiration, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK180991 AG 100sHospitech Respiration, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK221477 AG100sHospitech Respiration, Ltd. · 2022
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 3 of 3 · 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) | K093126 | Anapnoguard Endotracheal Tube | Hospitech Respiration, Ltd. | 2010 | — |
| +1 | K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration, Ltd. | 2016 | — |
| +2 | K180991 | AG 100s | Hospitech Respiration, Ltd. | 2018 | — |
| +3 | K221477 | AG100s | Hospitech Respiration, Ltd. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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.
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K082520 | Sealguard Evac Endotracheal and Endotracheal TubesSummary page 2…: Substantial cquivalence to the following predicate devices is claimed: ,,,,, S |aManufacturer, ;%';SIOIE*NGE iDateioffapproval SealGuard Endotracheal Covidien Tube k082520 | Oct 2, 2008 :)::ll Lead Endotracheal Well Lead k042683 | Feb 18, 2005 Performance Standards AnapnoGuard™ Endotracheal Tube was… | 2008 |
| * | K042683 | Well Lead Endotracheal TubeSummary page 2…ices is claimed: ,,,,, S |aManufacturer, ;%';SIOIE*NGE iDateioffapproval SealGuard Endotracheal Covidien Tube k082520 | Oct 2, 2008 :)::ll Lead Endotracheal Well Lead k042683 | Feb 18, 2005 Performance Standards AnapnoGuard™ Endotracheal Tube was tested and complies with the following standards: e ISO 5… | 2005 |
| † | K021142 | All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865 | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150157 | AnapnoGuard 100 Respiratory Guard System | 2016 | 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.
- 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 14 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 7 of the 8 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K150157 (Hospitech Respiration, Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K082520.
How does its category compare?
All BTP devicesBTP Dropper, Ether: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · BTP
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · BTP
Too few BTP 510(k)s in any year since 2007 to give a median.
Recalls per year · BTP
No recall names BTP since 2007.
Adverse event reports per year · BTP
No MAUDE report names BTP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093126: Anapnoguard Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093126
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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