Product code MQS
- Device name
- System, Hemodialysis, Access Recirculation Monitoring
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023-12-14 |
| K180410 | Dosis SAM | Dosis, Inc. | 2019-01-16 |
| K130579 | PHYSOFT AMS | Physicians Software Systems, LLC | 2013-12-19 |
| K042566 | VASC-ALERT | Vasc-Alert, Inc. | 2004-11-08 |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Transonic Systems, Inc. | 2002-12-04 |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Transonic Systems, Inc. | 2002-08-12 |
| K001763 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 2000-12-20 |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 2000-01-20 |
| K992227 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1999-07-30 |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Hewlett-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-CO | Transonic 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 MONITOR | Cobe Renal Care, Inc. | 1997-02-06 |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | In-Line Diagnostics Corp. | 1996-07-23 |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Fresenius USA, Inc. | 1996-07-03 |
| K953551 | KNOW-RECIRC | H&H Control Systems | 1996-06-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00861858000310 | PhySoftAMS | PHYSICIAN SOFTWARE SYSTEMS, LLC | 2026-05-27 |
| 00860005737512 | Smart Anemia Manager (SAM) | Dosis Inc. | 2021-03-09 |
| 00877466000468 | Transonic | TRANSONIC SYSTEMS INC. | 2020-10-01 |
| 00877466000437 | Transonic | TRANSONIC SYSTEMS INC. | 2020-10-01 |
| 00877466000451 | Transonic | TRANSONIC SYSTEMS INC. | 2020-10-01 |
| 00877466005791 | Transonic | TRANSONIC SYSTEMS INC. | 2020-10-01 |
| 00861858000303 | PhySoft AMS | PHYSICIAN SOFTWARE SYSTEMS, LLC | 2016-09-26 |
| 08774660000466 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-28 |
| 08774660000473 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-28 |
| 08774660005799 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-28 |
| 08774660005805 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-28 |
| 08774660000428 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-21 |
| 08774660000435 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-21 |
| 08774660000442 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-21 |
| 08774660000459 | Transonic | TRANSONIC SYSTEMS INC. | 2016-04-21 |