510(k) · Cleared
ClearedRusch Edgar Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Aug 1, 2002 as substantially equivalent to K931163 (Rusch, Inc., 1993) and 4 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1996. 4 of the 8 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 1, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K961837 (1996). 6 ancestors in all, the oldest K834463 (1984). 1 later device descends from it, 1 citing it directly. 4 of the 8 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 deviceK021540 Rusch Edgar TubeRusch Intl. · 2002
- Descendant · cites it directly · 0 of its ownK023964 Rusch Microlaryngeal TubeRusch Intl. · 2002
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…direct predicate · 2000
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eyedirect predicate · 1993
- K931166 Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYdirect predicate · 1993
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy2 generations back · 1996
Most influential descendants
Showing 1 of 1 · See all- K023964Rusch Microlaryngeal TubeRusch Intl. · 2002 · cites it directly0descendants
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) | K021540 | Rusch Edgar Tube | Rusch Intl. | 2002 | — |
| +1 | K023964 | Rusch Microlaryngeal Tube | Rusch Intl. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1993 | 2 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (7)
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 |
|---|---|---|---|
| * | K931163 | Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeSummary page 1…ubstantially equivalent in design and materials to: 0 Rusch Safety Tracheal Tubes - Preamendment 0 Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 0 Rusch Oral/Nasal (Safety Clear PlusTM)Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 0… | 1993 |
| * | K931166 | Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYSummary page 1…ally equivalent in design and materials to: 0 Rusch Safety Tracheal Tubes - Preamendment 0 Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 0 Rusch Oral/Nasal (Safety Clear PlusTM)Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 0 The Huds… | 1993 |
| * | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphySummary page 1…Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 0 Rusch Oral/Nasal (Safety Clear PlusTM)Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 0 The Hudson RCI Sheridan ETC02 Uncuffed Tubes - K861454 0 The Hudson RCI Sheridan LITA Cuffed Tracheal Tubes - K83… | 2000 |
| * | K861454 | End Tidal CO2 TubeSummary page 1…6 0 Rusch Oral/Nasal (Safety Clear PlusTM)Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 0 The Hudson RCI Sheridan ETC02 Uncuffed Tubes - K861454 0 The Hudson RCI Sheridan LITA Cuffed Tracheal Tubes - K834463 0 The Mallinckrodt Emergency Medical Tube (EMT) - 51… | 1986 |
| * | K834463 | Laryngotracheal Topical Anes. AppliSummary page 1…, Magill/Murphy, Sterile - K993786 0 The Hudson RCI Sheridan ETC02 Uncuffed Tubes - K861454 0 The Hudson RCI Sheridan LITA Cuffed Tracheal Tubes - K834463 0 The Mallinckrodt Emergency Medical Tube (EMT) - 510(k) # Unknown Page 2 4. Description of the De… | 1984 |
| * | — | Rusch Safety Tracheal Tubes - Preamendment Named without a submission number | |
| * | — | The Mallinckrodt Emergency Medical Tube (EMT) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023964 | Rusch Microlaryngeal Tube | 2002 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
- K931166Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 19 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
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 4 of the 6 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K023964 (Rusch Intl., 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K931163.
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.
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 Rusch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021540: Rusch Edgar Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021540
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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