Cleared Traditional

Fresenius Liberty Select Cycler (K171652) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171652 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (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.

View all Fresenius Medical Care Renal Therapies Group, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
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
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
K102936 · Baxter Healthcare Corp · Mar 2011
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
K053512 · Baxter Healthcare Corp · Feb 2006
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001