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Low Recirculation Volume APD Set with Cassette (4-Prong Spike) 5C8302C

by Vantive US Healthcare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

9 closed

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 Number07332414208356 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · FDA

    • Terminated Z-0947-2008 FDA Unclassified (pre-2012) initiated 20 Nov 2007

    Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.

    • Terminated Z-0139-06 FDA Unclassified (pre-2012) initiated 12 Sep 2005

    The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.

    • Terminated Z-1019-05 FDA Unclassified (pre-2012) initiated 21 Jun 2005

    The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard.

    • Terminated Z-0397-05 FDA Unclassified (pre-2012) initiated 23 Dec 2004

    A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.

  • 2 recalls, same reason

    • Terminated Z-0188-05 FDA Unclassified (pre-2012) initiated 1 Nov 2004
    • Terminated Z-0189-05 FDA Unclassified (pre-2012) initiated 1 Nov 2004

    The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.

    • Terminated Z-1013-04 FDA Unclassified (pre-2012) initiated 24 May 2004 on shared 510(k) K012988

    A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.

  • 2 recalls, same reason

    • Terminated Z-0564-03 FDA Unclassified (pre-2012) initiated 23 Dec 2002
    • Terminated Z-0565-03 FDA Unclassified (pre-2012) initiated 23 Dec 2002

    Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Low Recirculation Volume APD Set with Cassette (4-Prong Spike)
Generic Name
Peritoneal dialysis system tubing set
Model / Ref / Catalog
5C8302C
Primary DI / UDI-DI
07332414208356
510(k) Number
FDA Product Code
FKX
GMDN Term
Peritoneal dialysis system tubing set
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K012988)

Other devices from Vantive US Healthcare, LLC

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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