System, Hemodialysis, Access Recirculation Monitoring
The Hemodialysis Access Recirculation Monitoring System is a urology device used to detect and measure recirculation within hemodialysis vascular access sites (arteriovenous fistulas or grafts), ensuring effective dialysis delivery by alerting clinicians to access dysfunction. Classified as FDA Class 2 under 21 CFR 876.5820, it requires 510(k) premarket notification. The product code is MQS, and it carries a life-sustaining support flag reflecting the critical nature of hemodialysis.
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Basic Information
- Product Code
- MQS
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232283 | PhySoftAMS® | Dec 14, 2023 | Substantially Equivalent | Physician Software Systems, LLC |
| K180410 | Dosis SAM | Jan 16, 2019 | Substantially Equivalent | Dosis, Inc. |
| K130579 | PHYSOFT AMS | Dec 19, 2013 | Substantially Equivalent | Physicians Software Systems, LLC |
| K042566 | VASC-ALERT | Nov 08, 2004 | Substantially Equivalent | Vasc-Alert, Inc. |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Dec 04, 2002 | Substantially Equivalent | Transonic Systems, Inc. |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Aug 12, 2002 | Substantially Equivalent | Transonic Systems, Inc. |
| K001763 | CRIT-LINE MONITOR III (CLM III) | Dec 20, 2000 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Jan 20, 2000 | Substantially Equivalent | Hewlett-Packard Co. |
| K992227 | CRIT-LINE MONITOR III (CLM III) | Jul 30, 1999 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Apr 30, 1999 | Substantially Equivalent | Hewlett-Packard Co. |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | Oct 09, 1998 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | Oct 06, 1998 | Substantially Equivalent | Transonic Systems, Inc. |
| K972470 | CRIT-LINE MONITOR (CLMIII) | Dec 11, 1997 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | Feb 11, 1997 | Substantially Equivalent | Transonic Systems, Inc. |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | Feb 06, 1997 | Substantially Equivalent | Cobe Renal Care, Inc. |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | Jul 23, 1996 | Substantially Equivalent | In-Line Diagnostics Corp. |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Jul 03, 1996 | Substantially Equivalent | Fresenius USA, Inc. |
| K953551 | KNOW-RECIRC | Jun 21, 1996 | Substantially Equivalent | H&H Control Systems |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.