510(k) · Cleared
ClearedVascular Architects Aspire Covered Stent and 718 Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Architects, Inc. · JCT Prosthesis, Tracheal, Expandable
Cleared on Aug 1, 2003 as substantially equivalent to K003173 (Vascular Architects, Inc., 2001) and 2 other predicates after a 66-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Aug 1, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003173 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 2 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 1 generation backK030567 Modification to Vascular Architects Aspire Covered Stent and…Vascular Architects, Inc. · 2003
- This deviceK031641 Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −2 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −1 | K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled… | Vascular Architects, Inc. | 2003 | — |
| 0 (this device) | K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery System | Vascular Architects, Inc. | 2003 | — |
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? (3)
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 |
|---|---|---|---|
| * | K003173 | Aspire Covered Stent and Delivery CatheterSummary page 4…aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms. Predicate Devices K 003173 — Vascular Architects aSpire® Covered Stent and Delivery Catheter K012544 — Vascular Architects aSpire® Covered Stent and Contro… | 2001 |
| * | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemSummary page 3…and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006 Indications for Use 510(k) Number (if known): K031641 Device Name: Vascular Architects aSpire® C… | 2001 |
| * | K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…Summary page 3…ological Devices Office of Device Evaluation Center for Devices and Radiological Health Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006 Indications for Use 510(k) Number (if known): K031641 Device Name: Vascular Architects aSpire® Covered St… | 2003 |
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 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K003173.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031641: Vascular Architects Aspire Covered Stent and 718 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031641
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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