Cleared Traditional

K043363 - FRESENIUS LIBERTY CYCLER

K043363 is an FDA 510(k) clearance for FRESENIUS LIBERTY CYCLER, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K043363 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
114d
Days
Class 2
Risk

K043363 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 (Lexington, US). The FDA issued a Cleared decision on March 31, 2005 after a review of 114 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 North America devices

FDA 510(k) Submission Details - K043363

510(k) Number K043363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2004
Decision Date March 31, 2005
Days to Decision 114 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
17d faster than avg
Panel avg: 131d · This submission: 114d
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 K043363.
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
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001
FRSENIUS PD IQCARD CYCLER
K002892 · Fresenius Medical Care North America · Apr 2001
EASY CARE AND TUBING SETS
K994218 · Medionics International, Inc. · Feb 2000