Cleared Traditional

K141145 - LIBERTY PDX CYCLER

K141145 is the FDA 510(k) clearance for LIBERTY PDX CYCLER by Fresenius Medical Care Renal Therapies Group, LLC. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K141145 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
89d
Days
Class 2
Risk

K141145 is an FDA 510(k) clearance for the LIBERTY PDX 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 July 30, 2014 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fresenius Medical Care Renal Therapies Group, LLC devices

Submission Details

510(k) Number K141145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2014
Decision Date July 30, 2014
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 44
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K141145.
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K181108 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
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Fresenius Liberty Select Cycler
K171652 · Fresenius Medical Care Renal Therapies Group, LLC · Sep 2017
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K102936 · Baxter Healthcare Corp · Mar 2011
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FRESENIUS LIBERTY CYCLER
K043363 · Fresenius Medical Care North America · Mar 2005