Product code MQS— Gastroenterology, Urology

FDA has cleared 18 devices under product code MQS between 1996 and 2023, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20191 clearance
• 20131 clearance
• 20041 clearance
• 20022 clearances
• 20002 clearances
• 19992 clearances
• 19982 clearances
• 19973 clearances
• 19963 clearances

• In-Line Diagnostics Corp.5 clearances
• Transonic Systems, Inc.4 clearances
• Hewlett-Packard Co.2 clearances
• Vasc-Alert, Inc.1 clearance
• Physicians Software Systems, LLC1 clearance
• Physician Software Systems, LLC1 clearance
• H&H Control Systems1 clearance
• Fresenius USA, Inc.1 clearance
• Dosis, Inc.1 clearance
• Cobe Renal Care, Inc.1 clearance

• K232283 — PhySoftAMS®Physician Software Systems, LLC·2023-12-14
• K180410 — Dosis SAMDosis, Inc.·2019-01-16
• K130579 — PHYSOFT AMSPhysicians Software Systems, LLC·2013-12-19
• K042566 — VASC-ALERTVasc-Alert, Inc.·2004-11-08
• K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.·2002-12-04
• K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.·2002-08-12
• K001763 — CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.·2000-12-20
• K993587 — HP M2376A DEVICE LINK SYSTEMHewlett-Packard Co.·2000-01-20
• K992227 — CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.·1999-07-30
• K984194 — HP M2376A DEVICE LINK SYSTEMHewlett-Packard Co.·1999-04-30
• K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.·1998-10-09
• K980906 — TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COTransonic Systems, Inc.·1998-10-06
• K972470 — CRIT-LINE MONITOR (CLMIII)In-Line Diagnostics Corp.·1997-12-11
• K960817 — HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)Transonic Systems, Inc.·1997-02-11
• K954003 — COBE HEMODYNAMIC RECIRCULATION MONITORCobe Renal Care, Inc.·1997-02-06
• K953875 — CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)In-Line Diagnostics Corp.·1996-07-23
• K941460 — FRESENIUS BLOOD TEMPERATURE MONITORFresenius USA, Inc.·1996-07-03
• K953551 — KNOW-RECIRCH&H Control Systems·1996-06-21