# K171652: Fresenius Liberty Select Cycler

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Sep 15, 2017 after 102 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923065 (1994). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123630: Fresenius Liberty Cycler, Fresenius Medical Care North America, Design Cente (2013) Summary page 4.
- K141145: Liberty PDX Cycler, Fresenius Medical Care Renal Therapies Group, LLC (2014) Summary page 4.

## Most influential descendants
- K181108: Fresenius Liberty Select Cycler (2018), 3 descendants of its own
- K243371: Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (2025), 0 descendants of its own
- K222318: Fresenius Liberty Select Cycler (2022), 0 descendants of its own
- K212522: Lilliput APD System (2022), 0 descendants of its own

## Recalls of this device
- Sep 12, 2020 · Class II · Z-0439-2021: The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and t
- Jan 24, 2018 · Class II · Z-1365-2018: The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfil

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

Source page: https://510kreport.com/device/K171652
Methodology: https://510kreport.com/methodology