FDA applicant
Alung Technologies, Inc.
FDA records 1 decision for Alung Technologies, Inc. (Pittsburgh, PA) in 2021: 1 De Novo grant. All are in product code QOH (Extracorporeal System For Carbon Dioxide Removal). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alung Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2021high 1 (2021) · low 0 (2022)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Alung Technologies, 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