510(k) · Cleared

Cleared

Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System

K012544510(k) TraditionalCleared Nov 15, 2001100-day reviewClass II21 CFR 878.3720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vascular Architects, Inc. · JCT Prosthesis, Tracheal, Expandable

Cleared on Nov 15, 2001 as substantially equivalent to K003173 (Vascular Architects, Inc., 2001) after a 100-day review. Its family tree reaches back 1 generation to 2001. 21 later devices descend from it.

Decided: Nov 15, 2001
Review: 100 days
Class: Class II
Product code: JCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003173 (2001). 21 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
This deviceK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
Descendant · cites it directly · 18 of its ownK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
Descendant · cites it directly · 15 of its ownK033990 Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
Descendant · 2 generations on · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
Descendant · 2 generations on · 14 of its ownK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
Descendant · 3 generations on · 11 of its ownK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003high 4 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 21 · See all

K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003 · cites it directly18descendants
K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · cites it directly15descendants
K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · 2 generations on15descendants
K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007 · 2 generations on14descendants
K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · 3 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003173	Aspire Covered Stent and Delivery Catheter	Vascular Architects, Inc.	2001	—
0 (this device)	K012544	Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery…	Vascular Architects, Inc.	2001	—
+1	K030947	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	—
+1	K033990	Alveolus Inc. TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2004	—
+2	K033053	Alveolus, TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2004	—
+2	K062511	Aero Tracheobronchial Stent System, Model 90129-2XX	Alveolus, Inc.	2007	—
+3	K082284	Aero Tracheobronchial Stent Technology System	Alveolus, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	4	0
2004	2	0
2007	1	0
2008	1	0
2009	1	0
2012	1	0
2013	1	0
2014	3	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K012544, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K003173	Aspire Covered Stent and Delivery Catheter Summary page 4 …tent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms. Predicate Devices K003173 — Vascular Architects aSpire® Covered Stent and Delivery Catheter Device Description The Vascular Architects aSpire® Covered St…	Vascular Architects, Inc.	2001	—

Also cleared against K003173: 4 other devices →

What descends from it? (21)

See all 21

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030947	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	18
K033990	Alveolus Inc. TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2004	15
K030567	Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…	Vascular Architects, Inc.	2003	1
K032744	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	0
K031641	Vascular Architects Aspire Covered Stent and 718 Delivery System	Vascular Architects, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K030947 (Alveolus, Inc., 2003) has gone furthest, with 18 descendants of its own.
4 other devices also cite its predicate K003173.

How does its category compare?

All JCT devices

JCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCT

1in 2023

2007high 3 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JCT

234in 2014

2007high 234 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JCT

2in 2011

2007high 46 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JCT

50in 2025

2007high 251 (2015) · low 50 (2025)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/K012544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012544: Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012544

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026