← Back to catalogue

Liberty Cycler Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173718

by Fresenius Medical Care Renal Therapies Group, LLC

Identifiers

510(k) Number
K173718 FDA 510(k)
FDA Product Code
FKX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5630 FDA 510(k)
Regulation Number
876.5630 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Liberty Cycler Set is a peritoneal automatic delivery system. It is classified as a Class II medical device under the FDA product code FKX and regulation number 876.5630.

The device received FDA 510(k) clearance (K173718) on May 1, 2018, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Fresenius Medical Care Renal Therapies Group, LLC in Waltham, MA.

Frequently asked questions

What is the Liberty Cycler Set used for?

The Liberty Cycler Set is a peritoneal automatic delivery system designed to automate the delivery and drainage of dialysate during peritoneal dialysis treatments, helping to remove waste and excess fluid from the blood in patients with kidney failure.

How is the Liberty Cycler Set supplied and is it reusable?

The Liberty Cycler Set is supplied as a single-use, sterile disposable set intended for one patient per treatment cycle; it is not designed for cleaning, disinfection, or reuse due to infection risk and material degradation concerns.

What regulatory pathway was used for the Liberty Cycler Set?

The Liberty Cycler Set received FDA 510(k) clearance through a traditional review process under submission K173718, demonstrating substantial equivalence to a legally marketed predicate device in the same product code FKX.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Liberty Select Cycler - FMCNA, PDF Liberty Cycler User's Guide, FRESENIUS MEDICAL CARE LIBERTY MANUAL Pdf Download, Fresenius medical care Liberty Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

  • FDA 510(k) K173718 24 fields · synced Sep 22, 2026