# K923065: Baxter Personal Cycler Autommated Peritoneal Dial

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 4, 1994 after 617 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469 (2001), 17 descendants of its own
- 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

## Recalls of this device
- Jul 6, 2012 · Class II · Z-2132-2012: Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Se
- Nov 20, 2007 · Not classified · Z-0946-2008: 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
- Jun 21, 2005 · Not classified · Z-1018-05: 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 electric shock hazard.
- May 24, 2004 · Not classified · Z-1012-04: 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

Source page: https://510kreport.com/device/K923065
Methodology: https://510kreport.com/methodology