Alung Technologies, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Alung Technologies, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QOH | Extracorporeal System For Carbon Dioxide Removal | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210006 | De Novo | Extracorporeal System For Carbon Dioxide Removal | 2021-11-13 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-12-18.
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.
Device clinical trials
An industry sponsor named Alung Technologies, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01021605: Feasibility Study of the Hemolung Respiratory Assist System (Germany) (Completed, started 2009-12)
- NCT00987740: Feasibility Study of the Hemolung Respiratory Assist System (Completed, started 2009-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alung Technologies, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Alung Technologies, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Alung Technologies, Inc.?
The most frequent FDA product codes under this applicant name are QOH (Extracorporeal System For Carbon Dioxide Removal, 1).
Next steps
- See all 0 Alung Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QOH, Alung Technologies, 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.