510(k) · Cleared
ClearedThrough the Scope Tracheal Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · JCT Prosthesis, Tracheal, Expandable
Cleared on Jul 8, 2022 as substantially equivalent to K202204 (Micro-Tech (Nanjing) Co., Ltd., 2021) after a 144-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jul 8, 2022
- Review
- 144 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003173 (2001). 12 ancestors in all, the oldest K894380 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 6 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 5 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 4 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 3 generations backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- 2 generations backK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- 1 generation backK202204 Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2021
- This deviceK220424 Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −6 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −5 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −4 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −3 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| −2 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| −1 | K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
| 0 (this device) | K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 JCT? 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 JCT device
- #1 K230269 Ultraflex™ Tracheobronchial Stent Systemscore 8.1 · 9 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 |
|---|---|---|---|
| * | K202204 | Tracheal Stent SystemSummary page 5…Review Panel: Anesthesiology 1 of 7 4. Identification of Predicate Device 510(k) Number: K202204 Product Name: Tracheal Stent System (OTW) Manufacturer: Micro-Tech (Nanjing) Co., Ltd. 5. Indications for Use… | 2021 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JCT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JCT
234in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCT
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCT
50in 2025
MAUDE reports naming product code JCT, 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 | 2 | — | 0 | 150 |
| 2008 | 1 | — | 0 | 143 |
| 2009 | 1 | — | 0 | 163 |
| 2010 | 0 | — | 46 | 147 |
| 2011 | 0 | — | 2 | 95 |
| 2012 | 1 | — | 0 | 109 |
| 2013 | 0 | — | 0 | 238 |
| 2014 | 3 | 234 | 0 | 168 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 1 | — | 0 | 217 |
| 2017 | 0 | — | 0 | 109 |
| 2018 | 1 | — | 0 | 122 |
| 2019 | 0 | — | 0 | 106 |
| 2020 | 1 | — | 0 | 120 |
| 2021 | 2 | — | 0 | 106 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 1 | — | 0 | 110 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 50 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Through the Scope Tracheal Stent System is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220424: Through the Scope Tracheal Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220424
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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