Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Alveolus, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

99 daysmedian FDA review time
156 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083625AERO DV TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2009-03-11930
K082284AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEMAlveolus, Inc.2008-11-201010
K080838ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEMAlveolus, Inc.2008-04-24300
K072720ALIMAXX-B UNCOVERED BILIARY STENT SYSTEMAlveolus, Inc.2008-04-111996
K071604ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2007-09-19990
K062511AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XXAlveolus, Inc.2007-01-311560
K060239ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEMAlveolus, Inc.2006-03-22500
K051621ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEMAlveolus, Inc.2005-07-11210
K033990ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2004-05-121410
K033053ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2004-02-251490
K032744ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2003-11-13700
K030947ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2003-05-15500

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda