# DEN210006: Hemolung Respiratory Assist System

- Pathway: De Novo (Direct)
- Applicant: Alung Technologies, Inc.
- Decided: Nov 13, 2021 after 254 days
- Product code: QOH (Extracorporeal System For Carbon Dioxide Removal)
- Device class: 2
- Regulation: 21 CFR 870.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Hemolung Respiratory Assist System is indicated for respiratory support that provides extracorporeal carbon dioxide (CO2) removal from the patient's blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.

Source page: https://510kreport.com/device/DEN210006
Methodology: https://510kreport.com/methodology