# K130579: Physoft Ams

- Pathway: 510(k) (Traditional)
- Applicant: Physicians Software Systems, LLC
- Decided: Dec 19, 2013 after 289 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960817 (1997). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093834: Crit-Line Anemia Management Software, Hema Metrics, LLC (2010) Summary page 1.

## Most influential descendants
- K232283: PhySoftAMS® (2023), 0 descendants of its own
- K180410: Dosis SAM (2019), 0 descendants of its own

## Indications for use
PhySoft AMS'~ isa web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide aschedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS h isintended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients. The PhySoft AMS m is not a substitute for, but rather intended to assist, clinical judgment. The 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.

Source page: https://510kreport.com/device/K130579
Methodology: https://510kreport.com/methodology