Cleared Traditional

K171652 - Fresenius Liberty Select Cycler

K171652 is an FDA 510(k) clearance for Fresenius Liberty Select Cycler, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K171652 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
102d
Days
Class 2
Risk

K171652 is an FDA 510(k) clearance for the Fresenius Liberty Select Cycler. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on September 15, 2017 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K171652

510(k) Number K171652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date September 15, 2017
Days to Decision 102 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 131d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 65
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K171652.
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
K201867 · Baxter Healthcare Corporation · Nov 2020
Fresenius Liberty Select Cycler
K181108 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Liberty Cycler Set
K173718 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Amia Automated PD System with Sharesource
K151525 · Deka Research and Development · Oct 2015
LIBERTY PDX CYCLER
K141145 · Fresenius Medical Care Renal Therapies Group, LLC · Jul 2014
FRESENIUS LIBERTY CYCLER
K123630 · Fresenius Medical Care North America, Design Cente · Sep 2013