510(k) · Cleared
ClearedRusch Microlaryngeal 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 Dec 23, 2002 as substantially equivalent to K931163 (Rusch, Inc., 1993) and 5 other predicates after a 24-day review. Its family tree reaches back 3 generations to 1996. 4 of the 10 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 23, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K961837 (1996). 9 ancestors in all, the oldest K801005 (1980). No later device cites it as a predicate yet. 4 of the 10 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 backK021540 Rusch Edgar TubeRusch Intl. · 2002
- This deviceK023964 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
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 | K021540 | Rusch Edgar Tube | Rusch Intl. | 2002 | — |
| 0 (this device) | K023964 | Rusch Microlaryngeal Tube | Rusch Intl. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1993 | 2 | 2 |
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…in design and materials to: Rusch Safety Tracheal Tubes - Preamendment Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 Rusch Oral/Nasal (Safety Clear Plus”) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786… | 1993 |
| * | K931166 | Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYSummary page 1…in design and materials to: Rusch Safety Tracheal Tubes - Preamendment Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 Rusch Oral/Nasal (Safety Clear Plus”) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 Rusch… | 1993 |
| * | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphySummary page 1…Rusch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166 Rusch Oral/Nasal (Safety Clear Plus”) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786 Rusch Edgar Tube - KO21540 SheridanO (Now Hudson RCI) LTSm Tracheal Tube for Microlaryngeal Trachea… | 2000 |
| * | K021540 | Rusch Edgar Tube | 2002 |
| * | K860176 | Laryngectomy Tube, CuffedSummary page 1…ll/Murphy, Sterile - K993786 Rusch Edgar Tube - KO21540 SheridanO (Now Hudson RCI) LTSm Tracheal Tube for Microlaryngeal Tracheal Surgery - K860176 Mallinckrodt (Now Nellcor) MLTB Microlaryngeal Tracheal Tube - K801005 Page 2 4. D e… | 1986 |
| * | K801005 | MLT Tube Microlaryngeal Tracheal Tube)Summary page 1…Hudson RCI) LTSm Tracheal Tube for Microlaryngeal Tracheal Surgery - K860176 Mallinckrodt (Now Nellcor) MLTB Microlaryngeal Tracheal Tube - K801005 Page 2 4. D e s c r i p t i o n of t h e D e v i c e : The Rusch Microlaryngeal Tube will be offere… | 1980 |
| * | — | Rusch Safety Tracheal Tubes - Preamendment Named without a submission number |
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 · 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 2.5 years on median.
- 4 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- 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 Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023964: Rusch Microlaryngeal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023964
Report an extraction error
Are you the manufacturer?
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