FDA product code MQS: System, Hemodialysis, Access Recirculation Monitoring
MQS is the FDA product code for system, hemodialysis, access recirculation monitoring. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under MQS, 1 in the last five years, from 10 different applicants. The average 510(k) review took 242 days (median 177). FDA has posted 1 recall for MQS devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Hemodialysis, Access Recirculation Monitoring |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MQS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 336 |
| 2023 | 1 | 136 |
Compare with all 510(k) review times · Search every MQS clearance
Top MQS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| In-Line Diagnostics Corp. | 5 | 2000-12-20 |
| Transonic Systems, Inc. | 4 | 2002-12-04 |
| Hewlett-Packard Co. | 2 | 2000-01-20 |
| Physician Software Systems, LLC | 1 | 2023-12-14 |
| Dosis, Inc. | 1 | 2019-01-16 |
5 more applicants have MQS clearances. See the full list in Caduvo.
Most recent MQS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232283 | Physician Software Systems, LLC | PhySoftAMS® | 2023-12-14 | 136 |
| K180410 | Dosis, Inc. | Dosis SAM | 2019-01-16 | 336 |
| K130579 | Physicians Software Systems, LLC | PHYSOFT AMS | 2013-12-19 | 289 |
| K042566 | Vasc-Alert, Inc. | VASC-ALERT | 2004-11-08 | 48 |
| K022963 | Transonic Systems, Inc. | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | 2002-12-04 | 89 |
Recalls for MQS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-17.
Frequently asked questions
What is FDA product code MQS?
MQS is the FDA product code for system, hemodialysis, access recirculation monitoring. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is MQS?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQS?
Across 18 cleared submissions the average was 242 days from receipt to decision (median 177).
Which companies have the most MQS clearances?
In-Line Diagnostics Corp. (5); Transonic Systems, Inc. (4); Hewlett-Packard Co. (2); Physician Software Systems, LLC (1); Dosis, Inc. (1).
Have MQS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MQS
- Run a recall and safety report across every MQS manufacturer
- Watch product code MQS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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