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

• • Ongoing Z-0409-2026 FDA Class II ·initiated 28 Aug 2025

  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 the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

• • Ongoing Z-1316-2023 FDA Class II ·initiated 22 Feb 2023

  The electrical safety testing was not properly performed on the impacted devices and additional testing is required

510(k) Number

K201867 ↗

FDA Product Code

FKX

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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