Cleared Traditional

K123630 - FRESENIUS LIBERTY CYCLER

K123630 is an FDA 510(k) clearance for FRESENIUS LIBERTY CYCLER, manufactured by Fresenius Medical Care North America, Design Cente. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K123630 · Fresenius Medical Care North America, Design Cente · Gastroenterology & Urology device
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Sep 2013
Decision
290d
Days
Class 2
Risk

K123630 is an FDA 510(k) clearance for the FRESENIUS LIBERTY CYCLER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Fresenius Medical Care North America, Design Cente (Waltham, US). The FDA issued a Cleared decision on September 9, 2013 after a review of 290 days - an extended review cycle.

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 North America, Design Cente devices

FDA 510(k) Submission Details - K123630

510(k) Number K123630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date September 09, 2013
Days to Decision 290 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
159d slower than avg
Panel avg: 131d · This submission: 290d
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 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K123630.
Fresenius Liberty Select Cycler
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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
AMIA AUTOMATED PD SYSTEM
K124018 · Deka Research & Development Corp. · Jun 2013
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