510(k) · Cleared
ClearedRusch Safety Silk Series Oral/Nasal Tracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jun 6, 2014 as substantially equivalent to K993786 (Rusch Intl., 2000) and 1 other predicate after a 308-day review. Its family tree reaches back 2 generations to 1996. 2 of the 3 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 6, 2014
- Review
- 308 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961837 (1996). No later device cites it as a predicate yet. 2 of the 3 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 deviceK132415 Rusch Safety Silk Series Oral/Nasal Tracheal TubeTeleflexmedical, Inc. · 2014
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) | K132415 | Rusch Safety Silk Series Oral/Nasal Tracheal Tube | Teleflexmedical, Inc. | 2014 | — |
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 12.6 · 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? (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 |
|---|---|---|---|
| * | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphySummary page 1…per 21 CFR 868.5730, Product Code BTR) Predicate Devices Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786 Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy - K96 1837 Device Description The propose… | 2000 |
| * | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphySummary page 1…al/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786 Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy - K96 1837 Device Description The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use… | 1996 |
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 18 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- 5 other devices also cite its predicate K993786.
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. 2014, 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?
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132415: Rusch Safety Silk Series Oral/Nasal Tracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132415
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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