510(k) · Cleared
ClearedRusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Incorporated · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Feb 11, 2025 as substantially equivalent to K990619 (Rusch Intl., 1999) and 2 other predicates after a 265-day review. Its family tree reaches back 2 generations to 1996. 2 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 11, 2025
- Review
- 265 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961837 (1996). 3 ancestors in all. No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Recalled (Class I)
- 1 generation backK993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed…Rusch Intl. · 2000 · Recalled (Class I)
- This deviceK241451 Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes…Teleflex Incorporated · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy | Rusch Intl. | 1996 | Class I |
| −1 | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy | Rusch Intl. | 2000 | Class I |
| 0 (this device) | K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety… | Teleflex Incorporated | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K990619 | Rusch Reinforced Endotracheal (or Tracheal) Tube- Cuffed and Uncuffed Murphy/Magill…Summary page 6…Anesthesia 510(k) Summary - Page 1 of 7 510(k) Submission Rusch Endotracheal Tubes E. Predicate Device K990619 Rusch Reinforced Endotracheal (or Tracheal) Tube K961837 Rusch Oral/Nasal Tracheal Tube/Safety Clear Plus Tracheal Tube K993786 R… | 1999 |
| * | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphySummary page 6…== 510(k) Submission Rusch Endotracheal Tubes E. Predicate Device K990619 Rusch Reinforced Endotracheal (or Tracheal) Tube K961837 Rusch Oral/Nasal Tracheal Tube/Safety Clear Plus Tracheal Tube K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube F. Dev… | 1996 |
| * | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphySummary page 6…Endotracheal Tubes E. Predicate Device K990619 Rusch Reinforced Endotracheal (or Tracheal) Tube K961837 Rusch Oral/Nasal Tracheal Tube/Safety Clear Plus Tracheal Tube K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube F. Device Description An endotracheal tube is a device that is inserted into… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Direct predicate · ◆ on the line of descent in FIG. 132 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 25.0 years on median.
- 3 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K990619.
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. 2025, 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?
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for oral or nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotracheal Tubes are intended to be used on all…
Read the full statement (123 words)
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for oral or nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241451: Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241451
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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