NQJ · Class II · 21 CFR 876.5540

FDA Product Code NQJ: Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use

Dual Lumen, Non-implanted, Peripheral Access Catheters Are Inserted In The Peripheral Arm Vein And Are Indicated For Temporary (up To 8 Hours) Ultrafiltration Treatment Of Patients With Fluid Overload.

Leading manufacturers include Nuwellis, Inc..

4
Total
4
Cleared
89d
Avg days
2003
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 28d recently vs 110d historically

FDA 510(k) Cleared Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use Devices (Product Code NQJ)

4 devices
1–4 of 4
Cleared Aug 13, 2025
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101)
K252226
Nuwellis, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 26, 2023
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
K233515
Nuwellis, Inc.
Gastroenterology & Urology · 55d

About Product Code NQJ - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code NQJ since 2003, with 4 receiving FDA clearance (average review time: 89 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under NQJ have taken an average of 28 days to reach a decision - down from 110 days historically, suggesting improved FDA processing for this classification.

NQJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →