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Sharesource Connectivity Platform for Use with the Amia APD System 5C9400

by Vantive US Healthcare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number57332414206319 UDI-DI Date22 Sep 2026ListedStatusListed GUDID: in commercial distribution

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sharesource Connectivity Platform for Use with the Amia APD System
Generic Name
Nephrology information system application software
Model / Reference
5C9400
Primary DI / UDI-DI
57332414206319
510(k) Number
FDA Product Code
FKX
GMDN Term
Nephrology information system application software
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K151525)

Other devices from Vantive US Healthcare, LLC

See all devices from Vantive US Healthcare, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No