510(k) · Cleared
ClearedRusch Tracheofix Set, Cuffed and Uncuffed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Jul 23, 2002 after a 55-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 23, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK021764 Rusch Tracheofix Set, Cuffed and UncuffedRusch Intl. · 2002
- Descendant · cites it directly · 1 of its ownK042684 Well Lead Tracheostomy TubeWell Lead Medical Instruments · 2005
- Descendant · 2 generations on · 0 of its ownK101721 Well Lead Tracheostomy Tube and Disposable Inner CannulaRegulatory and Marketing Services, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021764 | Rusch Tracheofix Set, Cuffed and Uncuffed | Rusch Intl. | 2002 | — |
| +1 | K042684 | Well Lead Tracheostomy Tube | Well Lead Medical Instruments | 2005 | — |
| +2 | K101721 | Well Lead Tracheostomy Tube and Disposable Inner Cannula | Regulatory and Marketing Services, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 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.
Planning a device in BTO? 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 BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 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 |
|---|---|---|---|
| * | — | Mallinckrodt Shiley DCT Tracheostomy Tube Cuffed and Uncuffed Named without a submission number | |
| * | — | Smiths Industries (SIMS Concord-Portex) D.I.C. (Disposable Inner Cannula) Tracheostomy… Named without a submission number | |
| * | — | Bivona Medical Technologies AIRE-CUP Tracheostomy Tube Named without a submission number | |
| * | — | Rusch Crystal Tracheostomy Tube Named without a submission number | |
| * | — | Rusch TracheoFlex Sets Named without a submission number | |
| † | K972423 | Rusch Tracheofix-Set | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042684 | Well Lead Tracheostomy Tube | 2005 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042684 (Well Lead Medical Instruments, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Rusch TracheoFix Set (TFS) is a single patient disposable tracheostomy tube for airway management of tracheostomized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021764: Rusch Tracheofix Set, Cuffed and Uncuffed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021764
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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