Cleared Special

Fresenius Liberty Select Cycler (K181108) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181108 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2018
Decision
27d
Days
Class 2
Risk

K181108 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 May 24, 2018 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Medical Care Renal Therapies Group, LLC devices

Submission Details

510(k) Number K181108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2018
Decision Date May 24, 2018
Days to Decision 27 days
Submission Type Special
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
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 36
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K181108.
Lilliput APD System
K212522 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2022
CloudCath Peritoneal Dialysis Drain Set Monitoring System
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Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
K201867 · Baxter Healthcare Corporation · Nov 2020
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