QJZ · Class II · 21 CFR 870.4100

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
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 99d recently vs 214d historically

FDA 510(k) Cleared Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure Devices (Product Code QJZ)

4 devices
1–4 of 4
Cleared Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
K261335
Medtronic, Inc.
Cardiovascular · 99d
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880
Medtronic, Inc.
Cardiovascular · 164d
Cleared Apr 15, 2024
Novalung ultimate kit (US)
K232926
Fresenius Medical Care Renal Therapies Group, LLC
Cardiovascular · 208d
Cleared Feb 21, 2020
Novalung System
K191407
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - QJZ Product Code

Recent submissions under QJZ have taken an average of 99 days to reach a decision - down from 214 days historically, suggesting improved FDA processing for this classification.

QJZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →