Alveolus, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Alveolus, Inc.” (first 2003, latest 2009), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 96 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | 8 | 8 |
| ESW | Prosthesis, Esophageal | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
Most recent Alveolus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | JCT | 2009-03-11 | 93 |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | JCT | 2008-11-20 | 101 |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | ESW | 2008-04-24 | 30 |
| K072720 | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM | FGE | 2008-04-11 | 199 |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | JCT | 2007-09-19 | 99 |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | JCT | 2007-01-31 | 156 |
| K060239 | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM | ESW | 2006-03-22 | 50 |
| K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | ESW | 2005-07-11 | 21 |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | JCT | 2004-05-12 | 141 |
| K033053 | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | JCT | 2004-02-25 | 149 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-04-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alveolus, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Alveolus, Inc.” (first 2003, latest 2009), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alveolus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alveolus, Inc. is 96 days.
Which FDA product codes appear under Alveolus, Inc.?
The most frequent FDA product codes under this applicant name are JCT (Prosthesis, Tracheal, Expandable, 8); ESW (Prosthesis, Esophageal, 3); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 12 Alveolus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JCT, Alveolus, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.