# K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 5, 2001 after 90 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923065 (1994). 1 ancestor in all.
17 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923065: Baxter Personal Cycler Autommated Peritoneal Dial, Baxter Healthcare Corp (1994) Summary page 1.

## Most influential descendants
- K043363: Fresenius Liberty Cycler (2005), 13 descendants of its own
- K123630: Fresenius Liberty Cycler (2013), 6 descendants of its own
- K141145: Liberty PDX Cycler (2014), 5 descendants of its own
- K053512: Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310 (2006), 5 descendants of its own
- K171652: Fresenius Liberty Select Cycler (2017), 4 descendants of its own

## Recalls of this device
- Nov 20, 2007 · Not classified · Z-0947-2008: 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
- Sep 12, 2005 · Not classified · Z-0139-06: 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 eff
- Jun 21, 2005 · Not classified · Z-1019-05: 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.
- Dec 23, 2004 · Not classified · Z-0397-05: 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.
- Nov 1, 2004 · Not classified · Z-0189-05: 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.
- Nov 1, 2004 · Not classified · Z-0188-05: 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.
- May 24, 2004 · Not classified · Z-1013-04: 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 a
- Dec 23, 2002 · Not classified · Z-0565-03: Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
- Dec 23, 2002 · Not classified · Z-0564-03: Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy

## Indications for use
The HomeChoice® Personal Cycler Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Source page: https://510kreport.com/device/K012988
Methodology: https://510kreport.com/methodology