510(k) · Cleared
ClearedWell Lead Tracheostomy Tube and Disposable Inner Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory and Marketing Services, Inc. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Mar 24, 2011 as substantially equivalent to K042684 (Well Lead Medical Instruments, 2005) after a 279-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Mar 24, 2011
- Review
- 279 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021764 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK021764 Rusch Tracheofix Set, Cuffed and UncuffedRusch Intl. · 2002
- 1 generation backK042684 Well Lead Tracheostomy TubeWell Lead Medical Instruments · 2005
- This deviceK101721 Well Lead Tracheostomy Tube and Disposable Inner CannulaRegulatory and Marketing Services, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021764 | Rusch Tracheofix Set, Cuffed and Uncuffed | Rusch Intl. | 2002 | — |
| −1 | K042684 | Well Lead Tracheostomy Tube | Well Lead Medical Instruments | 2005 | — |
| 0 (this device) | K101721 | Well Lead Tracheostomy Tube and Disposable Inner Cannula | Regulatory and Marketing Services, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K042684 | Well Lead Tracheostomy TubeSummary page 2…ate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation. Predicate Device: K042684 - Well Lead Tracheostomy Tubes Substantial Equivalence: The proposed device is substantial equivalent to the Well Lead Tracheo… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
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. 2011, this device’s year, is highlighted.
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 Well Lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient
disposable tracheostomy tube for airway management of tracheostomnotized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101721: Well Lead Tracheostomy Tube and Disposable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101721
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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