FDA Product Code MQS: System, Hemodialysis, Access Recirculation Monitoring
Leading manufacturers include Hewlett-Packard Co., Dosis, Inc. and 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
Cleared
Dec 14, 2023
PhySoftAMS®
Physician Software Systems, LLC
Gastroenterology & Urology
136d
Cleared
Jan 16, 2019
Dosis SAM
Dosis, Inc.
Gastroenterology & Urology
336d
Cleared
Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
Hewlett-Packard Co.
Gastroenterology & Urology
90d
Cleared
Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
Hewlett-Packard Co.
Gastroenterology & Urology
158d
Cleared
Jul 03, 1996
FRESENIUS BLOOD TEMPERATURE MONITOR
Fresenius USA, Inc.
Gastroenterology & Urology
831d
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.