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Amia Automated PD System with Sharesource

by Deka Research and Development 510(k)

Active United States Open recall

510(k) K151525

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151525 Date9 Oct 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-0550-2024 FDA Class II initiated 15 Nov 2023

    There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

  • 2 recalls, same reason

    • Terminated Z-2174-2021 FDA Class II initiated 30 Jun 2021
    • Terminated Z-2173-2021 FDA Class II initiated 30 Jun 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) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

  • 2 recalls, same reason

    • Terminated Z-0850-2019 FDA Class II initiated 11 Dec 2018
    • Terminated Z-0849-2019 FDA Class II initiated 11 Dec 2018

    Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

    • Terminated Z-2597-2018 FDA Class II initiated 12 Jul 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.

    • Terminated Z-3133-2017 FDA Class II initiated 1 Sep 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 with Cassette.

    • Terminated Z-1565-2016 FDA Class II initiated 16 Feb 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 recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

Specification

510(k)

510(k) Number
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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