MQS · Class II · 21 CFR 876.5820

FDA Product Code MQS: System, Hemodialysis, Access Recirculation Monitoring

Leading manufacturers include Physician Software Systems, LLC.

18
Total
18
Cleared
242d
Avg days
1996
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Hemodialysis, Access Recirculation Monitoring Devices (Product Code MQS)

18 devices
1–18 of 18

About Product Code MQS - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code MQS since 1996, with 18 receiving FDA clearance (average review time: 242 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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