Cleared Traditional

K141019 - AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM (FDA 510(k) Clearance)

Also includes:
REFURBISHED
K141019 · Fenwal, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
50d
Days
-
Risk

K141019 is an FDA 510(k) clearance for the AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM. 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 June 10, 2014 after a review of 50 days - a notably fast clearance 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: 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 Fenwal, Inc. devices

Submission Details

510(k) Number K141019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2014
Decision Date June 10, 2014
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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