510(k) Report

FDA applicant

Alveolus, Inc.

Charlotte, NC12 decisions2003–20096 recalls

FDA records 12 decisions for Alveolus, Inc. (Charlotte, NC) from 2003 to 2009: 12 510(k) clearances. Most are in product codes JCT (Prosthesis, Tracheal, Expandable) and ESW (Prosthesis, Esophageal). Its devices cite 36 predicates, 11 of them its own earlier devices. 6 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Alveolus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22008: 32009: 1
2007high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

6in 2010

2010: 6
2007high 6 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Alveolus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alveolus, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JCTProsthesis, Tracheal, Expandable8decisions
  • ESWProsthesis, Esophageal3decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts1decision

Whose devices does it build on?

Its devices cite 36 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 20085cite it
  • K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 20034cite it
  • K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 20054cite it
  • K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 20083cite it
  • K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 20072cite it
  • K071604Alveolus Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 20071cites it

What has FDA decided for it lately?

  • K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
  • K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
  • K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
  • K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 20086 recalls
  • K071604Alveolus Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2007
  • K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
  • K060239Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemAlveolus, Inc. · 2006
  • K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005

All 12 as Alveolus, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x…Jan 28, 2010
  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x…Jan 28, 2010
  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x…Jan 28, 2010
  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x…Jan 28, 2010
  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x…Jan 28, 2010
  • K072720Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x…Jan 28, 2010