# K043363: Fresenius Liberty Cycler

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Mar 31, 2005 after 114 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: 2 generations back to K923065 (1994). 4 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902149: Fresenius/Delmed 90/2 Peritoneal Dialysis System, Fresenius/Delmed, Inc. (1990) 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.
- K002892: Frsenius PD Iqcard Cycler, Fresenius Medical Care North America (2001) Summary page 1.

## Most influential descendants
- K123630: Fresenius Liberty Cycler (2013), 6 descendants of its own
- K141145: Liberty PDX Cycler (2014), 5 descendants of its own
- K171652: Fresenius Liberty Select Cycler (2017), 4 descendants of its own
- K181108: Fresenius Liberty Select Cycler (2018), 3 descendants of its own
- K103220: Voyager Peritoneal Dialysis System (2011), 3 descendants of its own

## Recalls of this device
- Apr 28, 2021 · Class II · Z-2085-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions
- Dec 15, 2015 · Class II · Z-0693-2016: The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in 
- Oct 14, 2013 · Class II · Z-0148-2014: Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
- Jun 3, 2013 · Class II · Z-1674-2013: Cassette may leak during set up or during peritoneal dialysis treatment
- Oct 12, 2012 · Class II · Z-0799-2013: There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
- Mar 30, 2012 · Not classified · Z-1448-2012: Increased risk of intraperitoneal volume (IIPV), referred to as Overfill
- Sep 3, 2010 · Not classified · Z-0104-2011: Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
- Sep 3, 2010 · Not classified · Z-0105-2011: Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
- Sep 3, 2010 · Not classified · Z-0103-2011: Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.

## Indications for use
The Fresenius Liberty Cycler is intended for acute and chronic peritoneal dialysis.

Source page: https://510kreport.com/device/K043363
Methodology: https://510kreport.com/methodology