# K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Nov 19, 2020 after 135 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K923065 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102936: Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471R and 5C8310R, Baxter Healthcare Corp (2011) Summary page 5.
- K151525: Amia Automated PD System with Sharesource, Deka Research and Development (2015) Summary page 5.

## Recalls of this device
- Aug 28, 2025 · Class II · Z-0409-2026: Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that th
- Feb 22, 2023 · Class II · Z-1316-2023: The electrical safety testing was not properly performed on the impacted devices and additional testing is required

## Indications for use
Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities. 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/K201867
Methodology: https://510kreport.com/methodology