510(k) · Cleared
ClearedWell Lead Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Instruments · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Feb 17, 2005 as substantially equivalent to K021764 (Rusch Intl., 2002) after a 141-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Feb 17, 2005
- Review
- 141 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021764 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK021764 Rusch Tracheofix Set, Cuffed and UncuffedRusch Intl. · 2002
- This deviceK042684 Well Lead Tracheostomy TubeWell Lead Medical Instruments · 2005
- Descendant · cites it directly · 0 of its ownK101721 Well Lead Tracheostomy Tube and Disposable Inner CannulaRegulatory and Marketing Services, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K101721Well Lead Tracheostomy Tube and Disposable Inner CannulaRegulatory and Marketing Services, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021764 | Rusch Tracheofix Set, Cuffed and Uncuffed | Rusch Intl. | 2002 | — |
| 0 (this device) | K042684 | Well Lead Tracheostomy Tube | Well Lead Medical Instruments | 2005 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K021764 | Rusch Tracheofix Set, Cuffed and UncuffedSummary page 1…cation Name: Tracheostomy Tube Product Code: BTO Predicate Device: Rusch Tracheofix Set, Cuffed and Uncuffed - K021764 Intended Use: The device is a single patient disposable tracheostomy… | 2002 |
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 |
|---|---|---|---|
| K101721 | Well Lead Tracheostomy Tube and Disposable Inner Cannula | 2011 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K101721 (Regulatory and Marketing Services, Inc., 2011) has gone furthest, with 0 descendants 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 device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042684: Well Lead Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042684
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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