Cleared Traditional

K111702 - AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE

K111702 · Fenwal, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
279d
Days
-
Risk

K111702 is an FDA 510(k) clearance for the AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FO.... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fenwal, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on March 22, 2012 after a review of 279 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Fenwal, Inc. devices

FDA 510(k) Submission Details - K111702

510(k) Number K111702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2011
Decision Date March 22, 2012
Days to Decision 279 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
148d slower than avg
Panel avg: 131d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

LKN Device Classification - Class 0,

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

All 22
Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K111702.
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K113480 · Caridianbct, Inc.. · Jan 2012
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K071079 · Gambro Bct, Inc. · Aug 2007
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
K060734 · Fresenius Medical Care North America · Sep 2006