510(k) · Cleared
ClearedUltraflex Tracheobronchial Stent System- Sterile Uncovered
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · JCT Prosthesis, Tracheal, Expandable
Cleared on Aug 3, 2012 as substantially equivalent to K963241 (Boston Scientific Corp, 1996) and 4 other predicates after a 119-day review. Its family tree reaches back 7 generations to 2001. 5 later devices descend from it.
- Decided
- Aug 3, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K003173 (2001). 20 ancestors in all, the oldest K894380 (1989). 5 later devices descend from it, 3 citing it directly.
- 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 backK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- This deviceK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- Descendant · cites it directly · 2 of its ownK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · Recalled
- Descendant · cites it directly · 1 of its ownK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
- Descendant · cites it directly · 0 of its ownK230269 Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023
Most influential descendants
Showing 5 of 5 · See all- K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013 · cites it directly2descendants
- K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · 2 generations on1descendant
- K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · cites it directly1descendant
- K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026 · 3 generations on0descendants
- K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023 · cites it directly0descendants
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 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| 0 (this device) | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| +1 | K130004 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2013 | — |
| +2 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024 | 22 |
| +1 | K141584 | Ultraflex Tracheobronchial Covered Stent System | Boston Scientific Corporation | 2014 | 1 |
| +3 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent… | Boston Scientific Corporation | 2026 | — |
| +1 | K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K963241 | UltraflexSummary page 1…3. Predicate Device: Trade Name: UltraflexTM Tracheobronchial Stent System Manufacturer and Clearance No.: Boston Scientific Corporation, K963241; K0I 2883 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product code: JCT… | 1996 |
| * | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Summary page 2…The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate UltraflexTM Tracheobronchial Stern System (K012883, K963241). The retention suture material is identical to that of the predicate UltraflexTM Esophageal NG Stent System (K09 1816).… | 2001 |
| * | K091816 | Ultraflex Esophageal NG Stent SystemSummary page 1…ssification: Class 11 Trade Name: UltraflexTM Esophageal NG Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K09 1816 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product code: ESW C… | 2009 |
| * | K083625 | Aero DV Tracheobronchial Stent SystemSummary page 1…ade Name: Aero DVTM Tracheobronchial Stent System Manufacturer and Clearance Number: Alveolus Inc. (Merit Medical Endotek), K083625, K082284 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720. Product code: JCT… | 2009 |
| * | K082284 | Aero Tracheobronchial Stent Technology SystemSummary page 1…Aero DVTM Tracheobronchial Stent System Manufacturer and Clearance Number: Alveolus Inc. (Merit Medical Endotek), K083625, K082284 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720. Product code: JCT Cl… | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K130004 (Boston Scientific Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K963241.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 UltraflexTL{ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121048
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