# K102936: Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471R and 5C8310R

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 30, 2011 after 177 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923065 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053512: Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310, Baxter Healthcare Corp (2006) Summary page 1.
- K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469, Baxter Healthcare Corp (2001) Summary page 1.
- K923065: Baxter Personal Cycler Autommated Peritoneal Dial, Baxter Healthcare Corp (1994) Summary page 1.

## Most influential descendants
- 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
- Oct 10, 2018 · Class II · Z-0030-2020: Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path
- Jul 5, 2017 · Class II · Z-3041-2017: Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while 
- Jul 5, 2017 · Class II · Z-3040-2017: Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while
- Dec 16, 2016 · Class II · Z-1056-2017: Customer complaints received for the presence of leaks
- Jun 29, 2015 · Class III · Z-0291-2016: Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise co
- Dec 8, 2014 · Class II · Z-1039-2015: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
- Oct 21, 2014 · Class II · Z-1031-2015: The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
- Oct 6, 2014 · Class II · Z-0939-2015: There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
- Apr 3, 2014 · Class II · Z-1245-2015: Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small 
- Oct 16, 2013 · Class II · Z-1292-2015: The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may
- Oct 7, 2013 · Class II · Z-2609-2016: In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, 

## Indications for use
The HomeChoicelHomeChoice Pro 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/K102936
Methodology: https://510kreport.com/methodology