Alveolus, Inc.

Charlotte, NC, US

Alveolus, Inc. appears in FDA device records in Charlotte, NC. FDA records list 12 510(k) clearances between 2003-05-15 and 2009-03-11, no PMA records and no registered establishments. As of 2026-09-10, FDA records show one recall for this company.

510(k) clearances: 12
PMA records: 0
Recall records: 1
Registered establishments: 0

510(k) clearance history

FDA records hold 12 510(k) clearances for Alveolus, Inc. between 2003 and 2009. The busiest year on record is 2008, with 3. The most recent is 2009, with 1.

Clearances by year, as a table

510(k) clearance decisions for Alveolus, Inc., by decision year
Year	Clearances
2003	2
2004	2
2005	1
2006	1
2007	2
2008	3
2009	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K083625	AERO DV TRACHEOBRONCHIAL STENT SYSTEM	JCT	Unknown	2009-03-11
K082284	AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM	JCT	Unknown	2008-11-20
K080838	ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM	ESW	Substantially Equivalent	2008-04-24
K072720	ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM	FGE	Unknown	2008-04-11
K071604	ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM	JCT	Unknown	2007-09-19
K062511	AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX	JCT	Unknown	2007-01-31
K060239	ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM	ESW	Substantially Equivalent	2006-03-22
K051621	ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM	ESW	Substantially Equivalent	2005-07-11
K033990	ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM	JCT	Substantially Equivalent	2004-05-12
K033053	ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM	JCT	Substantially Equivalent	2004-02-25
K032744	ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM	JCT	Substantially Equivalent	2003-11-13
K030947	ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM	JCT	Substantially Equivalent	2003-05-15

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1487-04	Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202	The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.		2004-04-22	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain