# K103220: Voyager Peritoneal Dialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research & Development Corp.
- Decided: Jul 29, 2011 after 270 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923065 (1994). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 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.
- K043363: Fresenius Liberty Cycler, Fresenius Medical Care North America (2005) Summary page 1.

## Most influential descendants
- K124018: Amia Automated PD System (2013), 2 descendants of its own
- K151525: Amia Automated PD System with Sharesource (2015), 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

## Indications for use
The Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.

Source page: https://510kreport.com/device/K103220
Methodology: https://510kreport.com/methodology