510(k) · Cleared

Cleared

Alveolus Inc., TB-STS Tracheobronchial Stent System

K032744510(k) TraditionalCleared Nov 13, 200370-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

Alveolus, Inc. · JCT Prosthesis, Tracheal, Expandable

Cleared on Nov 13, 2003 as substantially equivalent to K030947 (Alveolus, Inc., 2003) and 3 other predicates after a 70-day review. Its family tree reaches back 3 generations to 2001.

Decided: Nov 13, 2003
Review: 70 days
Class: Class II
Product code: JCT
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K003173 (2001). 4 ancestors in all, the oldest K963241 (1996). No later device cites it as a predicate yet.

By dateBy generation

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 backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
This deviceK032744 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, 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	K030947	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	—
0 (this device)	K032744	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K032744, 2001–2003Source: 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? (4)

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
*	K030947	Alveolus Inc., TB-STS Tracheobronchial Stent System Summary page 4 …Stent System Classification: “Tracheal Prosthesis”, Product code: JCT Class li Predicate Devices Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947] Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241) Vascular Architects, Inc. a Spir…	Alveolus, Inc.	2003	—
*	K963241	Ultraflex Summary page 4 …ices Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947] Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241) Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]…	Boston Scientific Corp	1996	—
*	K003173	Aspire Covered Stent and Delivery Catheter Summary page 4 …traflex™ Tracheobronchial Stent System [510(k) Number K963241) Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544] - Description completely covered with a biocompatible polyurethane (ChronoFlexTM) membrane and is self-expanding.…	Vascular Architects, Inc.	2001	—
*	K012544	Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System Summary page 4 …cheobronchial Stent System [510(k) Number K963241) Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544] - Description completely covered with a biocompatible polyurethane (ChronoFlexTM) membrane and is self-expanding. The stent ex…	Vascular Architects, Inc.	2001	—

Also cleared against K030947: 3 other devices →

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 2 companies; a new generation was cleared every 8 months on median.
None of the 4 ancestors has a recall.
3 other devices also cite its predicate K030947.

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?

t 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/K032744 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032744: Alveolus Inc., TB-STS Tracheobronchial Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032744

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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