MQS · Class II · 21 CFR 876.5820

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

Leading manufacturers include In-Line Diagnostics Corp., Transonic Systems, Inc. and Hewlett-Packard Co..

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
Cleared Dec 14, 2023
PhySoftAMS®
K232283
Physician Software Systems, LLC
Gastroenterology & Urology · 136d
Cleared Jan 16, 2019
Dosis SAM
K180410
Dosis, Inc.
Gastroenterology & Urology · 336d
Cleared Dec 19, 2013
PHYSOFT AMS
K130579
Physicians Software Systems, LLC
Gastroenterology & Urology · 289d
Cleared Nov 08, 2004
VASC-ALERT
K042566
Vasc-Alert, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 04, 2002
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
K022963
Transonic Systems, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 12, 2002
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571
Transonic Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 20, 2000
CRIT-LINE MONITOR III (CLM III)
K001763
In-Line Diagnostics Corp.
Gastroenterology & Urology · 191d
Cleared Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
K993587
Hewlett-Packard Co.
Gastroenterology & Urology · 90d
Cleared Jul 30, 1999
CRIT-LINE MONITOR III (CLM III)
K992227
In-Line Diagnostics Corp.
Gastroenterology & Urology · 28d
Cleared Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
K984194
Hewlett-Packard Co.
Gastroenterology & Urology · 158d
Cleared Oct 09, 1998
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K982412
In-Line Diagnostics Corp.
Gastroenterology & Urology · 88d
Cleared Oct 06, 1998
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906
Transonic Systems, Inc.
Gastroenterology & Urology · 210d
Cleared Dec 11, 1997
CRIT-LINE MONITOR (CLMIII)
K972470
In-Line Diagnostics Corp.
Gastroenterology & Urology · 163d
Cleared Feb 11, 1997
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817
Transonic Systems, Inc.
Gastroenterology & Urology · 349d
Cleared Feb 06, 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003
Cobe Renal Care, Inc.
Gastroenterology & Urology · 531d
Cleared Jul 23, 1996
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
K953875
In-Line Diagnostics Corp.
Gastroenterology & Urology · 391d
Cleared Jul 03, 1996
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460
Fresenius USA, Inc.
Gastroenterology & Urology · 831d
Cleared Jun 21, 1996
KNOW-RECIRC
K953551
H&H Control Systems
Gastroenterology & Urology · 329d

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.