# K151525: Amia Automated PD System with Sharesource

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Oct 9, 2015 after 123 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923065 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124018: Amia Automated PD System, Deka Research & Development Corp. (2013) Summary page 4.
- K061515: Renalsoft, Baxter Healthcare Corp (2006) Summary page 4.

## Most influential descendants
- K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (2020), 0 descendants of its own

## Recalls of this device
- Nov 15, 2023 · Class II · Z-0550-2024: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
- Jun 30, 2021 · Class II · Z-2173-2021: Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) 
- Jun 30, 2021 · Class II · Z-2174-2021: Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) 
- Dec 11, 2018 · Class II · Z-0849-2019: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
- Dec 11, 2018 · Class II · Z-0850-2019: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
- Jul 12, 2018 · Class II · Z-2597-2018: There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
- Sep 1, 2017 · Class II · Z-3133-2017: The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set w
- Feb 16, 2016 · Class II · Z-1565-2016: Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total rec

## Indications for use
The Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients’ historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

Source page: https://510kreport.com/device/K151525
Methodology: https://510kreport.com/methodology