# K173718: Liberty Cycler Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 1, 2018 after 147 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 1 (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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043363: Fresenius Liberty Cycler, Fresenius Medical Care North America (2005) Summary page 4.

## Recalls of this device
- May 29, 2019 · Class II · Z-2151-2019: Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a p

## Indications for use
The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.

Source page: https://510kreport.com/device/K173718
Methodology: https://510kreport.com/methodology