510(k) · Decided

Decided

Aero Tracheobronchial Stent System, Model 90129-2XX

K062511510(k) TraditionalDecided Jan 31, 2007156-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 Jan 31, 2007 as substantially equivalent to K030947 (Alveolus, Inc., 2003) and 5 other predicates after a 156-day review. Its family tree reaches back 4 generations to 2001. 14 later devices descend from it.

Decided: Jan 31, 2007
Review: 156 days
Class: Class II
Product code: JCT
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K003173 (2001). 9 ancestors in all, the oldest K894380 (1989). 14 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
3 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
2 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
1 generation backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
This deviceK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
Descendant · cites it directly · 11 of its ownK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
Descendant · 2 generations on · 6 of its ownK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
Descendant · 3 generations on · 2 of its ownK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
Descendant · 4 generations on · 1 of its ownK233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008high 3 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 14 · See all

K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · cites it directly11descendants
K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · 2 generations on6descendants
K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · 2 generations on5descendants
K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013 · 3 generations on2descendants
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003173	Aspire Covered Stent and Delivery Catheter	Vascular Architects, Inc.	2001	—
−3	K012544	Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery…	Vascular Architects, Inc.	2001	—
−2	K030947	Alveolus Inc., TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2003	—
−1	K033053	Alveolus, TB-STS Tracheobronchial Stent System	Alveolus, Inc.	2004	—
0 (this device)	K062511	Aero Tracheobronchial Stent System, Model 90129-2XX	Alveolus, Inc.	2007	—
+1	K082284	Aero Tracheobronchial Stent Technology System	Alveolus, Inc.	2008	—
+2	K083625	Aero DV Tracheobronchial Stent System	Alveolus, Inc.	2009	—
+2	K121048	Ultraflex Tracheobronchial Stent System- Sterile Uncovered	Boston Scientific Corp	2012	—
+3	K130004	Ultraflex Esophageal NG Stent System	Boston Scientific Corporation	2013	—
+4	K233939	Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System	Boston Scientific	2024	22

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1996	1	0
1997	1	0
2001	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K062511, 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

Get a 510(k) Report

What was it cleared against? (6)

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 1 …esis", Product code: JOT 21 CIFR 878.3720 - Class II 16.2 Predicate Devices Alveolus, Inc. TB-STS~ Tracheolbronchial Stent System [510(k) Numbers K030947, K033053, K033990] Boston Scientific Corp. Inc. UltrafleXTm Tracheobronchial Stent System [501(k) Number K963241] Rusch Interna…	Alveolus, Inc.	2003	—
*	K033053	Alveolus, TB-STS Tracheobronchial Stent System Summary page 1 …oduct code: JOT 21 CIFR 878.3720 - Class II 16.2 Predicate Devices Alveolus, Inc. TB-STS~ Tracheolbronchial Stent System [510(k) Numbers K030947, K033053, K033990] Boston Scientific Corp. Inc. UltrafleXTm Tracheobronchial Stent System [501(k) Number K963241] Rusch International Po…	Alveolus, Inc.	2004	—
*	K033990	Alveolus Inc. TB-STS Tracheobronchial Stent System Summary page 1 …e: JOT 21 CIFR 878.3720 - Class II 16.2 Predicate Devices Alveolus, Inc. TB-STS~ Tracheolbronchial Stent System [510(k) Numbers K030947, K033053, K033990] Boston Scientific Corp. Inc. UltrafleXTm Tracheobronchial Stent System [501(k) Number K963241] Rusch International Polyflex St…	Alveolus, Inc.	2004	—
*	K963241	Ultraflex Summary page 1 …TB-STS~ Tracheolbronchial Stent System [510(k) Numbers K030947, K033053, K033990] Boston Scientific Corp. Inc. UltrafleXTm Tracheobronchial Stent System [501(k) Number K963241] Rusch International Polyflex Stent Kit [51 0(k) Number K01 3266] 16.3 Description The Alveolus Tracheolbronchial Stent Tech…	Boston Scientific Corp	1996	—
*	K013266	Rusch Polyflex Stent Kit Summary page 1 …K033053, K033990] Boston Scientific Corp. Inc. UltrafleXTm Tracheobronchial Stent System [501(k) Number K963241] Rusch International Polyflex Stent Kit [51 0(k) Number K01 3266] 16.3 Description The Alveolus Tracheolbronchial Stent Technology System is comprised of two CONFIDENTIAL Alv…	Rusch Intl.	2001	—
*	K971509	Endoxane Summary page 2 …eobronchial Stent System [501(k) Number K963241], the Rusch International Polyflex Stent Kit [510(k) Number K013266] and the Novatech S.A. Endoxane® Stent [510(k) Number K971509]. The 510(k) Notice references a report of a study conducted under IDE G040202 that was completed to demonstrate safety and effi…	Novatech SA	1997	—

Also cleared against K030947: 3 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K082284	Aero Tracheobronchial Stent Technology System	Alveolus, Inc.	2008	11
K140472	Bonastent Tracheal / Bronchial	Endochoice, Inc.	2014	1

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 6 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K082284 (Alveolus, Inc., 2008) has gone furthest, with 11 descendants of its own.
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. 2007, this device’s year, is highlighted.

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 Alveolus AERO™ Tracheobronchial Stent System is indicated 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/K062511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062511: Aero Tracheobronchial Stent System, Model 90129-2XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062511

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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