510(k) Report

510(k) · Cleared

Cleared

Aspire Covered Stent and Delivery Catheter

K003173510(k) TraditionalCleared Mar 13, 2001154-day reviewClass II21 CFR 878.3610

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

Vascular Architects, Inc. · ESW Prosthesis, Esophageal

Cleared on Mar 13, 2001 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Mar 13, 2001
Review
154 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
0

22 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2003: 4 descendants cleared2001: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2014: 3 descendants cleared2021: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2020: 1 descendant cleared2013: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
  2. Descendant · cites it directly · 21 of its ownK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
  3. Descendant · cites it directly · 18 of its ownK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
  4. Descendant · cites it directly · 15 of its ownK033990 Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
  5. Descendant · 2 generations on · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
  6. Descendant · 2 generations on · 14 of its ownK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2001: 12003: 42004: 22007: 12008: 12009: 12012: 12013: 12014: 32018: 12020: 12021: 12022: 12023: 12024: 12026: 1
2001high 4 (2003) · low 0 (2002)2026

Most influential descendants

Showing 5 of 22 · See all
  • K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc. · 2001 · cites it directly21descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003173Aspire Covered Stent and Delivery CatheterVascular Architects, Inc.2001—
+1K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery…Vascular Architects, Inc.2001—
+1K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.2003—
+1K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc.2004—
+2K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc.2004—
+2K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200340
200420
200710
200810
200910
201210
201310
201430
201810
202010
202110
202210
202310
202410
202610
FIG. 1 — Lineage of K003173, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ESW? 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 ESW device

  1. #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc.200121
K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200318
K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415
K032744Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.20030
K031641Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc.20030

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?

  • Of its descendants, K012544 (Vascular Architects, Inc., 2001) has gone furthest, with 21 descendants of its own.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ESW

3in 2025

2008: 52009: 32010: 32011: 12012: 22013: 22016: 12018: 22019: 12020: 12021: 42022: 12024: 42025: 32026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESW

90in 2025

2008: 99 days median2009: 35 days median2010: 206 days median2021: 139 days median2024: 130 days median2025: 90 days median
2007high 206 (2010) · low 35 (2009)2026

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

Recalls per year · ESW

25in 2010

2010: 25
2007high 25 (2010) · low 0 (2007)2026

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

Adverse event reports per year · ESW

120in 2025

2007: 882008: 1532009: 2392010: 2552011: 1402012: 1212013: 1452014: 1692015: 1752016: 1532017: 872018: 862019: 1672020: 1552021: 772022: 1092023: 1552024: 1662025: 120
2007high 255 (2010) · low 77 (2021)2025

MAUDE reports naming product code ESW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—088
20085990153
20093350239
2010320625255
20111—0140
20122—0121
20132—0145
20140—0169
20150—0175
20161—0153
20170—087
20182—086
20191—0167
20201—0155
20214139077
20221—0109
20230—0155
202441300166
20253900120
20261—0—

More from Vascular Architects, Inc.

5 FDA decisions under this applicant name. See the company

  • K031641Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc. · 2003
  • K030567Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery SystemVascular Architects, Inc. · 2003
  • K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc. · 2001
  • K003719Vascular Architects Periscope DeviceVascular Architects, Inc. · 2001

Recent decisions in ESW

The ESW category page

  • K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026
  • K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd. · 2025
  • K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd. · 2025
  • K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025
  • K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 202422 recalls

https://510kreport.com/device/K003173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003173: Aspire Covered Stent and Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003173

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026