FDA Product Code QNR: Blood Pump For Ecmo, Long-term (> 6 Hours) Use
ECMO provides prolonged cardiorespiratory support for patients with refractory heart or lung failure. FDA product code QNR covers blood pumps cleared for long-term ECMO use exceeding six hours.
These centrifugal or roller pumps drive extracorporeal blood flow through an oxygenator membrane, providing gas exchange and/or cardiac output support for days to weeks in patients with severe ARDS, cardiogenic shock, or as a bridge to transplantation.
QNR devices are Class II medical devices, regulated under 21 CFR 870.4100 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Cardiacassist, Inc., Abbott Medical and Medtronic, Inc..
FDA 510(k) Cleared Blood Pump For Ecmo, Long-term (> 6 Hours) Use Devices (Product Code QNR)
About Product Code QNR - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QNR since 2021, with 8 receiving FDA clearance (average review time: 187 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under QNR have taken an average of 117 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.
QNR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →