FDA Product Code QJZ: Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure.
Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC and Medtronic, Inc..
4
Total
4
Cleared
185d
Avg days
2020
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
132d
recently vs 239d historically
FDA 510(k) Cleared Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure Devices (Product Code QJZ)
4 devices
Cleared
Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
Medtronic, Inc.
Cardiovascular
99d
Cleared
Sep 12, 2024
VitalFlow Set with Balance Biosurface
Medtronic, Inc.
Cardiovascular
164d
Cleared
Apr 15, 2024
Novalung ultimate kit (US)
Fresenius Medical Care Renal Therapies Group, LLC
Cardiovascular
208d
Cleared
Feb 21, 2020
Novalung System
Fresenius Medical Care Renal Therapies Group, LLC
Cardiovascular
269d
About Product Code QJZ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QJZ since 2020, with 4 receiving FDA clearance (average review time: 185 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QJZ Product Code
Recent submissions under QJZ have taken an average of 132 days to reach a decision - down from 239 days historically, suggesting improved FDA processing for this classification.
QJZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →