510(k) · Cleared
ClearedMedsource Endotracheal Tube (with and Without Cuff)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsource International, LLC · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Oct 27, 2008 as substantially equivalent to K925505 (Rusch, Inc., 1993) and 4 other predicates after a 262-day review. Its family tree reaches back 3 generations to 1996. 4 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 27, 2008
- Review
- 262 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K961837 (1996). 10 ancestors in all, the oldest K871204 (1987). No later device cites it as a predicate yet. 4 of the 11 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 deviceK080339 Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC · 2008
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
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) | K080339 | Medsource Endotracheal Tube (with and Without Cuff) | Medsource International, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 1 |
| 1995 | 1 | 0 |
| 1996 | 1 | 1 |
| 2004 | 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? (5)
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 |
|---|---|---|---|
| * | K925505 | Rusch Safety Clear Plus Cuffed W/Murphy EyeSummary page 3…ting Description MedSource Predicate Devices Device (1) MedSource Endotracheal Tube K925505; K925506 (with and without cuff), (stylet RuschTM Flexi-Set® Cuffed ET Tube and Stylet Se… | 1993 |
| * | K925506 | Rusch Safety Clear Uncuffed with Murphy EyeSummary page 3…Description MedSource Predicate Devices Device (1) MedSource Endotracheal Tube K925505; K925506 (with and without cuff), (stylet RuschTM Flexi-Set® Cuffed ET Tube and Stylet Set… | 1993 |
| * | K952100 | Rusch Endotracheal Tube StyletSummary page 3…RuschTM Flexi-Set® Cuffed ET Tube and Stylet Set sold separately) K952100 K03 1794 (2) MedSource Pre-Loaded EndoFlexr m Tracheal Tube… | 1995 |
| * | K031794 | Endoflex Tracheal TubeSummary page 3…hTM Flexi-Set® Cuffed ET Tube and Stylet Set sold separately) K952100 K03 1794 (2) MedSource Pre-Loaded EndoFlexr m Tracheal Tube End… | 2004 |
| * | K042683 | Well Lead Endotracheal TubeSummary page 3…EndoFlexr m Tracheal Tube Endotracheal Tube and Stylet (Pre-loaded ET Tube with K042683 Stylet; with and without cuff). Well Lead TM ET Tube Intended Use The dev… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 10 ancestors have a recall of any class; 4 have a Class I recall.
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 device is intended for oral or nasal intubation and for airway management.
The device is intended for oral or nasal intubation and for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080339: Medsource Endotracheal Tube (with and Without Cuff).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080339
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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