510(k) · Cleared
ClearedPhySoftAMS®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physician Software Systems, LLC · MQS System, Hemodialysis, Access Recirculation Monitoring
Cleared on Dec 14, 2023 as substantially equivalent to K130579 (Physicians Software Systems, LLC, 2013) after a 136-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Dec 14, 2023
- Review
- 136 days
- Class
- Class II
- Product code
- MQS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960817 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 5 generations backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- 4 generations backK030456 Vasc-AlertVasc-Alert, LLC · 2003
- 3 generations backK042566 Vasc-AlertVasc-Alert, Inc. · 2004
- 2 generations backK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
- 1 generation backK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
- This deviceK232283 PhySoftAMS®Physician Software Systems, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −5 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| −4 | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| −3 | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
| −2 | K093834 | Crit-Line Anemia Management Software | Hema Metrics, LLC | 2010 | — |
| −1 | K130579 | Physoft Ams | Physicians Software Systems, LLC | 2013 | — |
| 0 (this device) | K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K130579.
How does its category compare?
All MQS devicesMQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MQS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MQS
Too few MQS 510(k)s in any year since 2007 to give a median.
Recalls per year · MQS
No recall names MQS since 2007.
Adverse event reports per year · MQS
5in 2013
MAUDE reports naming product code MQS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 68 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PhySoft Anemia Management System® (PhySoftAMS®) is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoftAMS® is intended to help physicians, nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic…
Read the full statement (157 words)
The PhySoft Anemia Management System® (PhySoftAMS®) is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoftAMS® is intended to help physicians, nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® is not a substitute for, but is rather intended to assist, clinical judgment. The erythropoiesis-stimulating agent (ESA) dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional’s clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232283: PhySoftAMS®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026