# K232283: PhySoftAMS®

- Pathway: 510(k) (Traditional)
- Applicant: Physician Software Systems, LLC
- Decided: Dec 14, 2023 after 136 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: 6 generations back to K960817 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130579: Physoft Ams, Physicians Software Systems, LLC (2013) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K232283
Methodology: https://510kreport.com/methodology