# K053512: Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 16, 2006 after 62 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923065 (1994). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469, Baxter Healthcare Corp (2001) Summary page 1.

## Most influential descendants
- K103220: Voyager Peritoneal Dialysis System (2011), 3 descendants of its own
- K124018: Amia Automated PD System (2013), 2 descendants of its own
- K151525: Amia Automated PD System with Sharesource (2015), 1 descendant of its own
- K102936: Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471R and 5C8310R (2011), 1 descendant of its own
- K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (2020), 0 descendants of its own

## Recalls of this device
- Mar 16, 2011 · Not classified · Z-2129-2011: Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of bums, electroc
- Jan 8, 2010 · Not classified · Z-0799-2010: Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
- Jan 8, 2010 · Not classified · Z-0800-2010: Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.

## Indications for use
The HomeChoice Automated 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/K053512
Methodology: https://510kreport.com/methodology