510(k) · Cleared
ClearedModification to Vascular Architects Aspire Covered Stent and Contrilled Expansion 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 Mar 24, 2003 as substantially equivalent to K012544 (Vascular Architects, Inc., 2001) after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Mar 24, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003173 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 1 generation backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- This deviceK030567 Modification to Vascular Architects Aspire Covered Stent and…Vascular Architects, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK031641 Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031641Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −1 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| 0 (this device) | K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled… | Vascular Architects, Inc. | 2003 | — |
| +1 | K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery System | Vascular Architects, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | 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): K030567 Device Name: . Vascular Architects aSpire®… | 2001 |
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 |
|---|---|---|---|
| K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery System | 2003 | 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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K031641 (Vascular Architects, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K012544.
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 Controlled Expansion® 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/K030567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030567: Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion 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/K030567
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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